{ "schemaVersion": "peptidescanner-official-document-reviews/v1", "boundary": "Scoped document inventories and selected section readings. Historical agency findings are not current prescribing advice or complete worldwide coverage. PDF pages are one-based file pages, which can differ from printed page numbers.", "reviews": [ { "peptideSlug": "abaloparatide", "version": 1, "publishedAt": "2026-09-16", "reviewedAt": "2026-09-16", "discovery": { "url": "https://www.ema.europa.eu/en/documents/report/documents-output-json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439", "scope": "English PDF entries containing Eladynos in the title in the retained September 15 EMA document-feed snapshot, plus selected FDA approval-package documents. Includes candidate associations, not a complete FDA inventory, national authorizations or worldwide coverage. Live EMA page requests returned HTTP 429 on September 16; fresh page reconciliation is pending." }, "documents": [ { "id": "ema-43729", "title": "Eladynos : EPAR - Refusal public assessment report", "url": "https://www.ema.europa.eu/en/documents/assessment-report/eladynos-epar-refusal-public-assessment-report_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2019-02-14", "feedApplicationId": "EMEA/H/C/004157", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-56405", "title": "CHMP summary of positive opinion for Eladynos", "url": "https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-eladynos_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2022-10-13", "feedApplicationId": null, "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-57149", "title": "Eladynos : EPAR - Medicine overview", "url": "https://www.ema.europa.eu/en/documents/overview/eladynos-epar-medicine-overview_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2022-12-22", "feedApplicationId": "EMEA/H/C/004157", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-57153", "title": "Eladynos : EPAR - Public assessment report", "url": "https://www.ema.europa.eu/en/documents/assessment-report/eladynos-epar-public-assessment-report_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2022-12-22", "feedApplicationId": "EMEA/H/C/004157", "status": "sections-reviewed", "note": "Resolved feed conflict: the PDF identifies EMEA/H/C/005928/0000 on page 1; the feed incorrectly associates this document with the older EMEA/H/C/004157 application. 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No payload or internal application identity was verified; the older application number in the feed remains unconfirmed for this document.", "reading": null }, { "id": "fda-abaloparatide-fda-2017", "title": "Tymlos: FDA clinical review (2016; 2017 approval package)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208743Orig1s000MedR.pdf", "authority": "FDA", "sourceUpdatedAt": "2016-12-08", "feedApplicationId": null, "note": "Historical approval-package review; later labels and postmarketing outcomes require separate reconciliation.", "status": "sections-reviewed", "reading": { "product": "Tymlos", "applicationId": "NDA 208743", "documentDate": "2016-12-08", "retrievedAt": "2026-09-16", "payloadSha256": "bf0cbf94a3346e43b2ce494a874baaff0dd57e918f09718955142b8266ea9287", "pageCount": 190, "identityPages": [ 1, 2 ], "readPages": [ 1, 2, 3, 4, 5, 17, 35, 126, 127 ], "scope": "Selected identity, benefit-risk, clinical evidence and limitations sections; not a complete dossier appraisal." } } ], "findings": [ { "heading": "Why do official accounts report different fracture results?", "text": "EMA’s 2022 assessment excluded two ACTIVE sites after good-clinical-practice findings, reducing the analysis population from 2,463 to 2,070. Vertebral-fracture benefit remained, but nonvertebral-fracture efficacy was not statistically established in that subset. The older FDA clinical review reported a nonvertebral-fracture reduction. These accounts use different analysis contexts; their estimates should not be pooled as independent trials.", "citations": [ { "documentId": "ema-57153", "pages": [ 180, 181, 182 ] }, { "documentId": "fda-abaloparatide-fda-2017", "pages": [ 17 ] } ] }, { "heading": "What did EMA conclude, and what remained uncertain?", "text": "The 2022 CHMP assessment supported authorization for postmenopausal osteoporosis at increased fracture risk after considering the total evidence. It retained cardiovascular uncertainty in vulnerable patients and requested an EU safety study. The reviewed report does not establish today’s completion status of that study.", "citations": [ { "documentId": "ema-57153", "pages": [ 188, 189, 190 ] } ] }, { "heading": "Which studies overlap?", "text": "ACTIVE (BA058-05-003) and its extension BA058-05-005 are a study family. The extension followed prior participants receiving alendronate; it was not an independent replication of the original randomized trial.", "citations": [ { "documentId": "ema-57153", "pages": [ 180, 181 ] } ] } ], "studies": [ { "protocolId": "BA058-05-003", "nctId": "NCT01343004", "registryUrl": "https://clinicaltrials.gov/study/NCT01343004", "registryPayloadSha256": "cc57d1682c01db36de069969d0e65a1b4d6fb8ef9333348304f0ee0d688b4b54", "registryRetrievedAt": "2026-09-16", "citations": [ { "documentId": "ema-57153", "pages": [ 180 ] } ] }, { "protocolId": "BA058-05-005", "nctId": "NCT01657162", "registryUrl": "https://clinicaltrials.gov/study/NCT01657162", "registryPayloadSha256": "9e3205d7a2c8672138f3fbf686be7f1ce1e070729ff66e1746bfcf6a09ede7b2", "registryRetrievedAt": "2026-09-16", "citations": [ { "documentId": "ema-57153", "pages": [ 181 ] } ] } ], "remainingWork": [ "Review the remaining EMA assessment, product-information, risk-management and change documents; reconcile historical applications separately.", "Reconcile later FDA supplements and current postmarketing-study status. Earlier review conclusions are dated evidence, not a current approval-status substitute.", "Complete full-text and correction appraisal of the related literature. Registry identity matching does not establish that all posted results or historical registry versions have been reviewed." ], "versionPath": "/peptides/abaloparatide/official-documents/versions/1/", "counts": { "inventoried": 10, "sectionsReviewed": 2, "notReviewed": 7, "unavailable": 1 } }, { "peptideSlug": "afamelanotide", "version": 1, "publishedAt": "2026-09-16", "reviewedAt": "2026-09-16", "discovery": { "url": "https://www.ema.europa.eu/en/documents/report/documents-output-json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439", "scope": "English PDF entries containing Scenesse in the title in the retained September 15 EMA document-feed snapshot, plus selected FDA approval-package documents. Includes candidate associations, not a complete FDA inventory, national authorizations or worldwide coverage. Live EMA page requests returned HTTP 429 on September 16; fresh page reconciliation is pending." }, "documents": [ { "id": "ema-14965", "title": "CHMP summary of positive opinion for Scenesse", "url": "https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-scenesse_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2014-10-24", "feedApplicationId": null, "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-17497", "title": "Scenesse recommended for rare disease that causes intolerance to sunlight", "url": "https://www.ema.europa.eu/en/documents/press-release/scenesse-recommended-rare-disease-causes-intolerance-sunlight_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2014-10-24", "feedApplicationId": null, "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-19438", "title": "Scenesse : EPAR - All Authorised presentations", "url": "https://www.ema.europa.eu/en/documents/all-authorised-presentations/scenesse-epar-all-authorised-presentations_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2015-02-12", "feedApplicationId": "EMEA/H/C/002548", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-25189", "title": "Scenesse : EPAR - Public assessment report", "url": "https://www.ema.europa.eu/en/documents/assessment-report/scenesse-epar-public-assessment-report_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2015-06-15", "feedApplicationId": "EMEA/H/C/002548", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-37594", "title": "Recommendation for maintenance of orphan designation at the time of marketing authorisation: Scenesse (afamelanotide) for the treatment of erythropoietic protoporphyria", "url": "https://www.ema.europa.eu/en/documents/orphan-review/recommendation-maintenance-orphan-designation-time-marketing-authorisation-scenesse-afamelanotide-treatment-erythropoietic-protoporphyria_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2015-02-17", "feedApplicationId": null, "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-41502", "title": "Scenesse : EPAR - Summary for the public", "url": "https://www.ema.europa.eu/en/documents/overview/scenesse-epar-summary-public_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2015-02-12", "feedApplicationId": "EMEA/H/C/002548", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-63429", "title": "Withdrawal letter: Scenesse", "url": "https://www.ema.europa.eu/en/documents/withdrawal-letter/withdrawal-letter-scenesse_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2024-05-31", "feedApplicationId": null, "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-64302", "title": "P/0101/2024 : EMA decision of 12 April 2024 on the acceptance of a modification of an agreed paediatric investigation plan for afamelanotide (Scenesse), (EMEA-000737-PIP02-11-M03)", "url": "https://www.ema.europa.eu/en/documents/pip-decision/p-0101-2024-ema-decision-12-april-2024-acceptance-modification-agreed-paediatric-investigation-plan-afamelanotide-scenesse-emea-000737-pip02-11-m03_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2024-07-25", "feedApplicationId": null, "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-69274", "title": "Scenesse : EPAR - Procedural steps taken and scientific information after authorisation", "url": "https://www.ema.europa.eu/en/documents/procedural-steps-after/scenesse-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2025-07-15", "feedApplicationId": "EMEA/H/C/002548", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-38510", "title": "Scenesse : EPAR - Risk management plan", "url": "https://www.ema.europa.eu/en/documents/rmp/scenesse-epar-risk-management-plan_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2025-10-17", "feedApplicationId": "EMEA/H/C/002548", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-33409", "title": "Scenesse : EPAR - Procedural steps taken and scientific information after authorisation (archive)", "url": "https://www.ema.europa.eu/en/documents/procedural-steps-after/scenesse-epar-procedural-steps-taken-scientific-information-after-authorisation-archive_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2025-10-17", "feedApplicationId": "EMEA/H/C/002548", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-72369", "title": "Scenesse-PAM-0000291457 : EPAR - Assessment report", "url": "https://www.ema.europa.eu/en/documents/variation-report/scenesse-pam-0000291457-epar-assessment-report_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2026-01-30", "feedApplicationId": "EMEA/H/C/002548", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-63430", "title": "Questions and answers on the withdrawal of application to change the marketing authorisation for Scenesse (afamelanotide)", "url": "https://www.ema.europa.eu/en/documents/medicine-qa/questions-answers-withdrawal-application-change-marketing-authorisation-scenesse-afamelanotide_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2026-03-05", "feedApplicationId": null, "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-72863", "title": "Withdrawal assessment report for Scenesse", "url": "https://www.ema.europa.eu/en/documents/withdrawal-report/withdrawal-assessment-report-scenesse_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2026-03-05", "feedApplicationId": null, "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-4290", "title": "Scenesse : EPAR - Product Information", "url": "https://www.ema.europa.eu/en/documents/product-information/scenesse-epar-product-information_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2025-10-21", "feedApplicationId": "EMEA/H/C/002548", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "fda-afamelanotide-fda-2019", "title": "Scenesse: FDA multidisciplinary review (2019)", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210797Orig1s000MultidisciplineR.pdf", "authority": "FDA", "sourceUpdatedAt": "2019-10-08", "feedApplicationId": null, "note": "Historical approval-package review; 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In CUV039, the sponsor’s analysis gave p=0.044; FDA’s analysis including missing-data assumptions gave p=0.055. FDA considered CUV029 supportive, while CUV030’s pain-free exposure analysis was post hoc.", "citations": [ { "documentId": "fda-afamelanotide-fda-2019", "pages": [ 19, 20, 118 ] } ] }, { "heading": "Which limitations affect interpretation?", "text": "FDA described diary-design and data-handling problems, different exposure windows and follow-up periods, and uncertainty about the quality-of-life instruments. Twenty-six participants from CUV030 could re-enroll in CUV039, so the trial enrollment totals do not represent entirely distinct people.", "citations": [ { "documentId": "fda-afamelanotide-fda-2019", "pages": [ 21, 117, 118, 119 ] } ] }, { "heading": "What safety work was requested?", "text": "The 2019 review requested a cardiac-repolarization study and a long-term registry addressing skin cancer, implant reactions, pregnancy and device issues. These were surveillance questions, not proof that the medicine caused those outcomes. Their current completion status has not been verified in this review.", "citations": [ { "documentId": "fda-afamelanotide-fda-2019", "pages": [ 144, 147, 148 ] } ] } ], "studies": [ { "protocolId": "CUV029", "nctId": "NCT00979745", "registryUrl": "https://clinicaltrials.gov/study/NCT00979745", "registryPayloadSha256": "2fd6110adf20fcbb44ef658743b5065e84da20974079495497c49a0ab596fcba", "registryRetrievedAt": "2026-09-16", "citations": [ { "documentId": "fda-afamelanotide-fda-2019", "pages": [ 60 ] } ] }, { "protocolId": "CUV039", "nctId": "NCT01605136", "registryUrl": "https://clinicaltrials.gov/study/NCT01605136", "registryPayloadSha256": "13406dbb57276643e4b47b84eb6040985cbb55525c426a6ce7ee2064ec82e51f", "registryRetrievedAt": "2026-09-16", "citations": [ { "documentId": "fda-afamelanotide-fda-2019", "pages": [ 60 ] } ] } ], "remainingWork": [ "Review the remaining EMA assessment, product-information, risk-management and change documents; reconcile historical applications separately.", "Reconcile later FDA supplements and current postmarketing-study status. Earlier review conclusions are dated evidence, not a current approval-status substitute.", "Complete full-text and correction appraisal of the related literature. Registry identity matching does not establish that all posted results or historical registry versions have been reviewed." ], "versionPath": "/peptides/afamelanotide/official-documents/versions/1/", "counts": { "inventoried": 16, "sectionsReviewed": 1, "notReviewed": 15, "unavailable": 0 } }, { "peptideSlug": "vosoritide", "version": 1, "publishedAt": "2026-09-16", "reviewedAt": "2026-09-16", "discovery": { "url": "https://www.ema.europa.eu/en/documents/report/documents-output-json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439", "scope": "English PDF entries containing Voxzogo in the title in the retained September 15 EMA document-feed snapshot, plus selected FDA approval-package documents. Includes candidate associations, not a complete FDA inventory, national authorizations or worldwide coverage. Live EMA page requests returned HTTP 429 on September 16; fresh page reconciliation is pending." }, "documents": [ { "id": "ema-51585", "title": "CHMP summary of positive opinion for Voxzogo", "url": "https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-voxzogo_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2021-06-25", "feedApplicationId": null, "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-52404", "title": "Voxzogo : EPAR - Public assessment report", "url": "https://www.ema.europa.eu/en/documents/assessment-report/voxzogo-epar-public-assessment-report_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2021-09-09", "feedApplicationId": "EMEA/H/C/005475", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-52411", "title": "Voxzogo : Orphan maintenance assessment report (initial authorisation)", "url": "https://www.ema.europa.eu/en/documents/orphan-maintenance-report/voxzogo-orphan-maintenance-assessment-report-initial-authorisation_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2021-09-09", "feedApplicationId": "EMEA/H/C/005475", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-54273", "title": "Voxzogo-H-C-005475-P46-007 : EPAR - Assessment report", "url": "https://www.ema.europa.eu/en/documents/variation-report/voxzogo-h-c-005475-p46-007-epar-assessment-report_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2022-02-24", "feedApplicationId": "EMEA/H/C/005475", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-59974", "title": "CHMP post-authorisation summary of positive opinion for Voxzogo (II-06)", "url": "https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-voxzogo-ii-06_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2023-09-15", "feedApplicationId": null, "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-52402", "title": "Voxzogo : EPAR - All authorised presentations", "url": "https://www.ema.europa.eu/en/documents/all-authorised-presentations/voxzogo-epar-all-authorised-presentations_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2021-09-09", "feedApplicationId": "EMEA/H/C/005475", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-52400", "title": "Voxzogo : EPAR - Medicine overview", "url": "https://www.ema.europa.eu/en/documents/overview/voxzogo-epar-medicine-overview_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2023-11-24", "feedApplicationId": "EMEA/H/C/005475", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-60980", "title": "Voxzogo-H-C-005475-II-0006 : EPAR - Assessment report - Variation", "url": "https://www.ema.europa.eu/en/documents/variation-report/voxzogo-h-c-005475-ii-0006-epar-assessment-report-variation_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2023-11-21", "feedApplicationId": "EMEA/H/C/005475", "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-61841", "title": "Direct healthcare professional communication (DHPC) : Voxzogo (vosoritide): change to administration syringe and needle leading to product administration in Units (U) instead of mL", "url": "https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-voxzogo-vosoritide-change-administration-syringe-and-needle-leading-product-administration-units-u-instead-ml_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2024-01-23", "feedApplicationId": null, "status": "not-reviewed", "note": "Discovered in the retained EMA document feed; 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Four participants from the separate 111-205 study had reached near-final height in the original submission; that small observation did not settle the final-height question.", "citations": [ { "documentId": "fda-vosoritide-fda-2021", "pages": [ 55, 56, 72, 73 ] } ] } ], "studies": [ { "protocolId": "111-301", "nctId": "NCT03197766", "registryUrl": "https://clinicaltrials.gov/study/NCT03197766", "registryPayloadSha256": "c28a6cd1ecc8aaa497ac7acb14ad330d3e493b8774699b6f427bf4ac70f6d2b5", "registryRetrievedAt": "2026-09-16", "citations": [ { "documentId": "fda-vosoritide-fda-2021", "pages": [ 25 ] } ] }, { "protocolId": "111-302", "nctId": "NCT03424018", "registryUrl": "https://clinicaltrials.gov/study/NCT03424018", "registryPayloadSha256": "378986d84a0f9d4ccc564992a889b3df7f0bfb3ccbe7167c5ff5b391f744dcdd", "registryRetrievedAt": "2026-09-16", "citations": [ { "documentId": "fda-vosoritide-fda-2021", "pages": [ 55, 56 ] } ] } ], "remainingWork": [ "Review the remaining EMA assessment, product-information, risk-management and change documents; reconcile historical applications separately.", "Reconcile later FDA supplements and current postmarketing-study status. 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This is a bounded inventory, not a complete FDA, national or worldwide source search." }, "documents": [ { "id": "ema-51223", "title": "CHMP summary of positive opinion for Imcivree", "url": "https://www.ema.europa.eu/en/documents/smop-initial/chmp-summary-positive-opinion-imcivree_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2021-05-21", "feedApplicationId": null, "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-52006", "title": "Imcivree : EPAR - All authorised presentations", "url": "https://www.ema.europa.eu/en/documents/all-authorised-presentations/imcivree-epar-all-authorised-presentations_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2022-11-03", "feedApplicationId": "EMEA/H/C/005089", "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-52007", "title": "Imcivree : EPAR - Public assessment report", "url": "https://www.ema.europa.eu/en/documents/assessment-report/imcivree-epar-public-assessment-report_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2021-07-22", "feedApplicationId": "EMEA/H/C/005089", "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; 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product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-40021", "title": "Victoza-H-C-1026-II-0023: EPAR - Assessment Report - Variation", "url": "https://www.ema.europa.eu/en/documents/scientific-discussion-variation/victoza-h-c-1026-ii-0023-epar-assessment-report-variation_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2014-06-26", "feedApplicationId": "EMEA/H/C/001026", "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-44923", "title": "CHMP post-authorisation summary of positive opinion for Victoza (II-49)", "url": "https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-victoza-ii-49_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2019-06-28", "feedApplicationId": null, "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; 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product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-60997", "title": "Direct Healthcare Professional Communication (DHPC) Ozempic (semaglutide) and Victoza (liraglutide): Supply shortage", "url": "https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-ozempic-semaglutide-victoza-liraglutide-supply-shortage_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2023-12-01", "feedApplicationId": null, "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-64684", "title": "Direct healthcare professional communication (DHPC) : Update on Ozempic (semaglutide) and Victoza (liraglutide): Supply shortage", "url": "https://www.ema.europa.eu/en/documents/dhpc/direct-healthcare-professional-communication-dhpc-update-ozempic-semaglutide-victoza-liraglutide-supply-shortage_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2024-09-02", "feedApplicationId": null, "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-4357", "title": "P/0086/2015: European medicines agency decision of 8 May 2015 on the acceptance of a modification of an agreed paediatric investigation plan for liraglutide (Victoza, Saxenda) (EMEA-000128-PIP02-09-M01)", "url": "https://www.ema.europa.eu/en/documents/pip-decision/p-0086-2015-european-medicines-agency-decision-8-may-2015-acceptance-modification-agreed-paediatric-investigation-plan-liraglutide-victoza-saxenda-emea-000128-pip02-09-m01_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2015-06-15", "feedApplicationId": null, "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-6006", "title": "P/0218/2017: EMA decision of 9 August 2017 on the acceptance of a modification of an agreed paediatric investigation plan for liraglutide (Victoza),\n\n(EMEA-000128-PIP01-07-M08)", "url": "https://www.ema.europa.eu/en/documents/pip-decision/p-0218-2017-ema-decision-9-august-2017-acceptance-modification-agreed-paediatric-investigation-plan-liraglutide-victoza-emea-000128-pip01-07-m08_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2017-09-29", "feedApplicationId": null, "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; 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This is a bounded inventory, not a complete FDA, national or worldwide source search." }, "documents": [ { "id": "ema-3547", "title": "Trulicity-H-C-PSUSA-10311-201609 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation", "url": "https://www.ema.europa.eu/en/documents/scientific-conclusion/trulicity-h-c-psusa-10311-201609-epar-scientific-conclusions-grounds-variation-terms-marketing-authorisation_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2017-07-04", "feedApplicationId": "EMEA/H/C/002825", "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-7481", "title": "Trulicity : EPAR - Medicine overview", "url": "https://www.ema.europa.eu/en/documents/overview/trulicity-epar-medicine-overview_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2023-03-16", "feedApplicationId": "EMEA/H/C/002825", "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-15349", "title": "Trulicity : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation", "url": "https://www.ema.europa.eu/en/documents/scientific-conclusion/trulicity-epar-scientific-conclusions-grounds-variation-terms-marketing-authorisation_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2016-12-15", "feedApplicationId": "EMEA/H/C/002825", "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-28747", "title": "Trulicity : EPAR - All Authorised presentations", "url": "https://www.ema.europa.eu/en/documents/all-authorised-presentations/trulicity-epar-all-authorised-presentations_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2021-05-19", "feedApplicationId": "EMEA/H/C/002825", "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-29560", "title": "Trulicity : EPAR - Public assessment report", "url": "https://www.ema.europa.eu/en/documents/assessment-report/trulicity-epar-public-assessment-report_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2014-12-19", "feedApplicationId": "EMEA/H/C/002825", "status": "sections-reviewed", "note": "PDF identity verified independently of the feed. 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product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-45471", "title": "CHMP post-authorisation summary of positive opinion for Trulicity (II-40)", "url": "https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-trulicity-ii-40_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2019-09-20", "feedApplicationId": null, "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-45943", "title": "Trulicity-H-C-2825-II-0040 : EPAR - Assessment report - Variation", "url": "https://www.ema.europa.eu/en/documents/variation-report/trulicity-h-c-2825-ii-0040-epar-assessment-report-variation_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2019-11-08", "feedApplicationId": "EMEA/H/C/002825", "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-50024", "title": "Trulicity-H-C-2825-X-0045 : EPAR - Assessment report - Variation", "url": "https://www.ema.europa.eu/en/documents/variation-report/trulicity-h-c-2825-x-0045-epar-assessment-report-variation_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2021-02-01", "feedApplicationId": "EMEA/H/C/002825", "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-51787", "title": "Trulicity-H-C-PSUSA-10311-202009 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s)", "url": "https://www.ema.europa.eu/en/documents/scientific-conclusion/trulicity-h-c-psusa-10311-202009-epar-scientific-conclusions-grounds-variation-terms-marketing-authorisations_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2021-07-05", "feedApplicationId": "EMEA/H/C/002825", "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-57411", "title": "CHMP post-authorisation summary of opinion for Trulicity (II-65)", "url": "https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-opinion-trulicity-ii-65_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2023-01-27", "feedApplicationId": null, "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-58037", "title": "Trulicity-H-C-2825-II-0065 : EPAR - Assessment report - Variation", "url": "https://www.ema.europa.eu/en/documents/variation-report/trulicity-h-c-2825-ii-0065-epar-assessment-report-variation_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2023-03-16", "feedApplicationId": "EMEA/H/C/002825", "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-57625", "title": "P/0409/2021 : EMA decision of 29 October 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dulaglutide (Trulicity), (EMEA-000783-PIP01-09-M06)", "url": "https://www.ema.europa.eu/en/documents/pip-decision/p-0409-2021-ema-decision-29-october-2021-acceptance-modification-agreed-paediatric-investigation-plan-dulaglutide-trulicity-emea-000783-pip01-09-m06_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2023-02-13", "feedApplicationId": null, "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-50586", "title": "P/0175/2020: EMA decision of 13 May 2020 on the acceptance of a modification of an agreed paediatric investigation plan for dulaglutide (Trulicity), (EMEA-000783-PIP01-09-M05)", "url": "https://www.ema.europa.eu/en/documents/pip-decision/p-0175-2020-ema-decision-13-may-2020-acceptance-modification-agreed-paediatric-investigation-plan-dulaglutide-trulicity-emea-000783-pip01-09-m05_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2021-03-16", "feedApplicationId": null, "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-14233", "title": "P/0227/2016: EMA decision of 26 August 2016 on the acceptance of a modification of an agreed paediatric investigation plan for dulaglutide\n\n(Trulicity), (EMEA-000783-PIP01-09-M04)", "url": "https://www.ema.europa.eu/en/documents/pip-decision/p-0227-2016-ema-decision-26-august-2016-acceptance-modification-agreed-paediatric-investigation-plan-dulaglutide-trulicity-emea-000783-pip01-09-m04_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2016-06-27", "feedApplicationId": null, "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-12783", "title": "P/0017/2016: EMA decision of 29 January 2016 on the acceptance of a modification of an agreed paediatric investigation plan for dulaglutide (Trulicity), (EMEA-000783-PIP01-09-M03)", "url": "https://www.ema.europa.eu/en/documents/pip-decision/p-0017-2016-ema-decision-29-january-2016-acceptance-modification-agreed-paediatric-investigation-plan-dulaglutide-trulicity-emea-000783-pip01-09-m03_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2016-03-29", "feedApplicationId": null, "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-31033", "title": "P/0105/2015: EMA decision of 29 April 2015 on the acceptance of a modification of an agreed paediatric investigation plan for dulaglutide (Trulicity) (EMEA-000783-PIP01-09-M02)", "url": "https://www.ema.europa.eu/en/documents/pip-decision/p-0105-2015-ema-decision-29-april-2015-acceptance-modification-agreed-paediatric-investigation-plan-dulaglutide-trulicity-emea-000783-pip01-09-m02_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2015-05-19", "feedApplicationId": null, "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-3409", "title": "Trulicity : EPAR - Procedural steps taken and scientific information after authorisation (archive)", "url": "https://www.ema.europa.eu/en/documents/procedural-steps-after/trulicity-epar-procedural-steps-taken-scientific-information-after-authorisation-archive_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2026-01-30", "feedApplicationId": "EMEA/H/C/002825", "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-72360", "title": "Trulicity : EPAR - Procedural steps taken and scientific information after authorisation", "url": "https://www.ema.europa.eu/en/documents/procedural-steps-after/trulicity-epar-procedural-steps-taken-scientific-information-after-authorisation_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2026-01-30", "feedApplicationId": "EMEA/H/C/002825", "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null }, { "id": "ema-11584", "title": "Trulicity : EPAR - Product information", "url": "https://www.ema.europa.eu/en/documents/product-information/trulicity-epar-product-information_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2026-01-30", "feedApplicationId": "EMEA/H/C/002825", "status": "not-reviewed", "note": "Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.", "reading": null } ], "findings": [ { "heading": "The original efficacy program focused on glycemic control", "text": "EMA’s 2014 review found HbA1c reductions across trials with different background therapies and comparators. Changes from baseline and between-group differences are different measures; they should not be pooled into a single headline effect.", "citations": [ { "documentId": "ema-29560", "pages": [ 165, 166 ] } ] }, { "heading": "Long exposure was much less common than any exposure", "text": "The phase 2/3 program included 4,006 participants exposed to dulaglutide, but only 642 for at least 78 weeks and 157 for at least 104 weeks. EMA identified this as a limitation for a treatment intended for chronic use.", "citations": [ { "documentId": "ema-29560", "pages": [ 168 ] } ] }, { "heading": "Background therapy changes the safety context", "text": "The review reports substantially greater hypoglycemia risk when dulaglutide was studied alongside insulin or a sulfonylurea. Comparing raw adverse-event rates without the accompanying regimen can mislead.", "citations": [ { "documentId": "ema-29560", "pages": [ 168 ] } ] }, { "heading": "This historical review precedes later evidence", "text": "The 2014 assessment described a cardiovascular outcomes trial as ongoing. It should be read alongside subsequent outcome studies and the separate 2022 pediatric FDA source note, not treated as the latest statement of all available evidence.", "citations": [ { "documentId": "ema-29560", "pages": [ 169 ] } ] } ], "studies": [], "remainingWork": [ "Read the later REWIND regulatory assessment and additional indication/strength variations.", "Reconcile the pediatric memo’s prose/table discrepancy before publishing a pooled HbA1c point estimate." ], "versionPath": "/peptides/dulaglutide/official-documents/versions/1/", "counts": { "inventoried": 22, "sectionsReviewed": 1, "notReviewed": 21, "unavailable": 0 } }, { "peptideSlug": "exenatide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "discovery": { "url": "https://www.ema.europa.eu/en/documents/report/documents-output-json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439", "scope": "One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading." }, "documents": [ { "id": "ema-36540", "title": "Byetta : EPAR - Scientific Discussion", "url": "https://www.ema.europa.eu/en/documents/scientific-discussion/byetta-epar-scientific-discussion_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2006-12-15", "feedApplicationId": "EMEA/H/C/000698", "status": "sections-reviewed", "note": "The undated initial scientific discussion names the product. Application identity comes from the separately pinned EMA medicine record, and the date is the documents-feed first-publication date, not an adoption date.", "reading": { "product": "Byetta", "applicationId": "EMEA/H/C/000698", "documentDate": "2006-12-15", "retrievedAt": "2026-09-19", "payloadSha256": "406dfeecb0b57c3036d836ebf625e6aad6182143b50820c441500b79c3a2d1df", "pageCount": 27, "identityPages": [ 1 ], "readPages": [ 1, 25, 26, 27 ], "scope": "Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal.", "legacyEmaMetadata": { "dateBasis": "ema-first-publication", "applicationSource": { "url": "https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "a947c2b8a56ac2b92ec96156843f262f5e516f83b375d6791d67a8f6dc695729", "recordId": "EMEA/H/C/000698" } } } } ], "findings": [ { "heading": "The original trials tested add-on diabetes treatment", "text": "EMA’s original Byetta assessment evaluated exenatide added to existing glucose-lowering therapy in type 2 diabetes. HbA1c was the principal endpoint; weight change was a separate outcome. This is not the later extended-release or cardiovascular-outcomes evidence.", "citations": [ { "documentId": "ema-36540", "pages": [ 25, 27 ] } ] }, { "heading": "The insulin comparisons had an important limitation", "text": "Two active-comparator trials met the prespecified HbA1c noninferiority margin. EMA noted their open-label design and the possibility that insulin treatment had not been fully optimized, limiting claims that one treatment was better overall.", "citations": [ { "documentId": "ema-36540", "pages": [ 25 ] } ] }, { "heading": "Extension results require caution", "text": "EMA warned that more than 80% of extension participants withdrew or discontinued for administrative reasons after week 52. Favorable results among those remaining cannot alone establish durable benefit for everyone originally enrolled.", "citations": [ { "documentId": "ema-36540", "pages": [ 25 ] } ] }, { "heading": "Safety depends on accompanying treatment and follow-up", "text": "The review identifies nausea and vomiting as common problems and hypoglycemia particularly with sulfonylureas. Mean exposure was under a year, with limited experience in older people and impaired kidney function.", "citations": [ { "documentId": "ema-36540", "pages": [ 26 ] } ] } ], "studies": [], "remainingWork": [ "Review the separate Bydureon extended-release assessment and EXSCEL cardiovascular program.", "Reconcile later safety variations and full-text trial reports with their original study populations." ], "versionPath": "/peptides/exenatide/official-documents/versions/1/", "counts": { "inventoried": 1, "sectionsReviewed": 1, "notReviewed": 0, "unavailable": 0 } }, { "peptideSlug": "ziconotide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "discovery": { "url": "https://www.ema.europa.eu/en/documents/report/documents-output-json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439", "scope": "One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading." }, "documents": [ { "id": "ema-28994", "title": "Prialt : EPAR - Scientific Discussion", "url": "https://www.ema.europa.eu/en/documents/scientific-discussion/prialt-epar-scientific-discussion_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2006-08-31", "feedApplicationId": "EMEA/H/C/000551", "status": "sections-reviewed", "note": "The undated initial scientific discussion names the product. Application identity comes from the separately pinned EMA medicine record, and the date is the documents-feed first-publication date, not an adoption date.", "reading": { "product": "Prialt", "applicationId": "EMEA/H/C/000551", "documentDate": "2006-08-31", "retrievedAt": "2026-09-19", "payloadSha256": "4617076b4f396aefe6db3b8a3b1e3545ac75a5f94b0162a797541d7b1f62a16e", "pageCount": 35, "identityPages": [ 1 ], "readPages": [ 1, 30, 31, 32, 33, 34 ], "scope": "Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal.", "legacyEmaMetadata": { "dateBasis": "ema-first-publication", "applicationSource": { "url": "https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "a947c2b8a56ac2b92ec96156843f262f5e516f83b375d6791d67a8f6dc695729", "recordId": "EMEA/H/C/000551" } } } } ], "findings": [ { "heading": "The evidence concerns severe pain requiring intrathecal treatment", "text": "EMA’s original Prialt discussion describes three placebo-controlled studies in severe chronic pain. Improvements were measured using pain-intensity scores, and the populations included malignant and non-malignant pain.", "citations": [ { "documentId": "ema-28994", "pages": [ 33, 34 ] } ] }, { "heading": "Short-term benefit did not establish long-term maintenance", "text": "The assessment found limited efficacy data beyond three weeks, particularly for malignant pain. Its positive assessment therefore included further observational follow-up; this historical document does not report the eventual outcome of that follow-up.", "citations": [ { "documentId": "ema-28994", "pages": [ 33, 34 ] } ] }, { "heading": "Neurological adverse effects were central", "text": "Confusion, memory impairment, dizziness and other neurological events were prominent. Later study conditions reduced some adverse effects, but EMA still described a narrow therapeutic window.", "citations": [ { "documentId": "ema-28994", "pages": [ 31, 32, 33 ] } ] }, { "heading": "Procedure and combination risks remain separate", "text": "The review discusses meningitis risk associated with intrathecal delivery and unresolved evidence for combinations with other intrathecal medicines. Results for this specialist route cannot establish benefit or safety for other preparations or routes.", "citations": [ { "documentId": "ema-28994", "pages": [ 30, 33, 34 ] } ] } ], "studies": [], "remainingWork": [ "Review later Prialt safety updates and long-term observational follow-up.", "Appraise original pain-trial reports by malignant versus non-malignant disease and prior intrathecal therapy." ], "versionPath": "/peptides/ziconotide/official-documents/versions/1/", "counts": { "inventoried": 1, "sectionsReviewed": 1, "notReviewed": 0, "unavailable": 0 } }, { "peptideSlug": "teriparatide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "discovery": { "url": "https://www.ema.europa.eu/en/documents/report/documents-output-json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439", "scope": "One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading." }, "documents": [ { "id": "ema-27569", "title": "Forsteo : EPAR - Scientific Discussion", "url": "https://www.ema.europa.eu/en/documents/scientific-discussion/forsteo-epar-scientific-discussion_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2005-10-21", "feedApplicationId": "EMEA/H/C/000425", "status": "sections-reviewed", "note": "The undated initial scientific discussion names the product. Application identity comes from the separately pinned EMA medicine record, and the date is the documents-feed first-publication date, not an adoption date.", "reading": { "product": "Forsteo", "applicationId": "EMEA/H/C/000425", "documentDate": "2005-10-21", "retrievedAt": "2026-09-19", "payloadSha256": "c0c59f61296f01a3e99817d905b3b96e724f35979e31ab741bab66889db9dec5", "pageCount": 22, "identityPages": [ 1 ], "readPages": [ 1, 20, 21, 22 ], "scope": "Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal.", "legacyEmaMetadata": { "dateBasis": "ema-first-publication", "applicationSource": { "url": "https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "a947c2b8a56ac2b92ec96156843f262f5e516f83b375d6791d67a8f6dc695729", "recordId": "EMEA/H/C/000425" } } } } ], "findings": [ { "heading": "Fracture outcomes differ from bone-density outcomes", "text": "EMA’s initial Forsteo discussion reports fewer new vertebral and non-vertebral fractures in postmenopausal women, but inconclusive results for individual sites such as the hip. Increased bone mineral density is a different endpoint.", "citations": [ { "documentId": "ema-27569", "pages": [ 21 ] } ] }, { "heading": "Both pivotal trials ended early", "text": "The assessment describes early termination of the pivotal trials and median treatment durations of 19 months in women and 11 months in men. These limits matter when interpreting persistence and uncommon adverse effects.", "citations": [ { "documentId": "ema-27569", "pages": [ 21 ] } ] }, { "heading": "The original male indication was disputed", "text": "In this initial assessment, the committee did not accept extrapolating fracture reduction in women to men solely from bone-density results. The original recommendation covered postmenopausal women; later indication extensions require separate review.", "citations": [ { "documentId": "ema-27569", "pages": [ 21, 22 ] } ] }, { "heading": "Animal findings prompted further surveillance", "text": "The review discusses rat osteosarcoma findings and the limits of the then-available human follow-up. It did not establish an observed human cancer risk; this historical concern must be distinguished from later surveillance and current labeling.", "citations": [ { "documentId": "ema-27569", "pages": [ 20, 21 ] } ] } ], "studies": [], "remainingWork": [ "Review subsequent male and glucocorticoid-induced osteoporosis assessments and current labels.", "Reconcile long-term human osteosarcoma surveillance and post-treatment fracture follow-up with this historical assessment." ], "versionPath": "/peptides/teriparatide/official-documents/versions/1/", "counts": { "inventoried": 1, "sectionsReviewed": 1, "notReviewed": 0, "unavailable": 0 } }, { "peptideSlug": "lixisenatide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "discovery": { "url": "https://www.ema.europa.eu/en/documents/report/documents-output-json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439", "scope": "One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading." }, "documents": [ { "id": "ema-28007", "title": "Lyxumia : EPAR - Public assessment report", "url": "https://www.ema.europa.eu/en/documents/assessment-report/lyxumia-epar-public-assessment-report_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2026-02-05", "feedApplicationId": "EMEA/H/C/002445", "status": "sections-reviewed", "note": "Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.", "reading": { "product": "Lyxumia", "applicationId": "EMEA/H/C/002445", "documentDate": "2012-11-28", "retrievedAt": "2026-09-19", "payloadSha256": "bb64000d8ce3d69605a1b93466e94e1f08615da94f32e7f6c684f8a1853e4922", "pageCount": 81, "identityPages": [ 1 ], "readPages": [ 1, 77, 78, 79, 80 ], "scope": "Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal." } } ], "findings": [ { "heading": "The initial assessment focused on glucose control", "text": "EMA’s November 2012 review found HbA1c improvements when lixisenatide was added to specified background therapies. Placebo-adjusted changes and changes from baseline differed, and results varied between trial populations.", "citations": [ { "documentId": "ema-28007", "pages": [ 77, 79 ] } ] }, { "heading": "A comparison did not robustly establish equivalence", "text": "EMA judged noninferiority to exenatide on glycemic and weight outcomes not robustly demonstrated. A favorable overall regulatory decision did not mean every comparative endpoint was established.", "citations": [ { "documentId": "ema-28007", "pages": [ 79 ] } ] }, { "heading": "Safety interpretation needs the background regimen", "text": "The review identifies gastrointestinal symptoms, injection-site and allergic reactions, with hypoglycemia principally alongside insulin or sulfonylureas. Evidence in people over 75 and those with substantial kidney impairment was limited.", "citations": [ { "documentId": "ema-28007", "pages": [ 77, 78, 79 ] } ] }, { "heading": "Keep the historical review separate from later status", "text": "ELIXA was still ongoing in this assessment. The downloaded PDF is now marked as a product no longer authorized, so its original favorable recommendation is not proof of current EU authorization or later cardiovascular benefit.", "citations": [ { "documentId": "ema-28007", "pages": [ 1, 80 ] } ] } ], "studies": [], "remainingWork": [ "Review ELIXA results separately from the original glucose-control program.", "Verify the withdrawal history and current jurisdiction-specific products without inferring a safety cause from the withdrawal watermark." ], "versionPath": "/peptides/lixisenatide/official-documents/versions/1/", "counts": { "inventoried": 1, "sectionsReviewed": 1, "notReviewed": 0, "unavailable": 0 } }, { "peptideSlug": "glucagon", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "discovery": { "url": "https://www.ema.europa.eu/en/documents/report/documents-output-json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439", "scope": "One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading." }, "documents": [ { "id": "ema-50305", "title": "Ogluo : EPAR - Public assessment report", "url": "https://www.ema.europa.eu/en/documents/assessment-report/ogluo-epar-public-assessment-report_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2021-02-26", "feedApplicationId": "EMEA/H/C/005391", "status": "sections-reviewed", "note": "Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.", "reading": { "product": "Ogluo", "applicationId": "EMEA/H/C/005391", "documentDate": "2020-12-10", "retrievedAt": "2026-09-19", "payloadSha256": "7cd33c516e2e3f15b9de4e3d25054354e74e316483d85afa02f37ddbe1463199", "pageCount": 114, "identityPages": [ 1 ], "readPages": [ 1, 106, 107, 108, 111, 112 ], "scope": "Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal." } } ], "findings": [ { "heading": "The pivotal question was recovery from hypoglycemia", "text": "EMA’s Ogluo review describes controlled studies of glucagon in people with diabetes. The pivotal adult endpoint was blood-glucose recovery within 30 minutes; the pediatric study was open-label.", "citations": [ { "documentId": "ema-50305", "pages": [ 106, 107 ] } ] }, { "heading": "Noninferiority did not mean identical recovery speed", "text": "The adult study met its noninferiority criterion, but EMA reported slower glucose recovery after administration than the reference product. Preparation time and the time measured after injection are distinct comparisons.", "citations": [ { "documentId": "ema-50305", "pages": [ 107, 108 ] } ] }, { "heading": "Usability studies answer a different question", "text": "Human-factors studies tested successful device use, including simulated emergencies. Their results support a usability assessment; they are not the same as observing clinical outcomes during spontaneous severe hypoglycemia.", "citations": [ { "documentId": "ema-50305", "pages": [ 107, 108, 111 ] } ] }, { "heading": "The formulation and population define the scope", "text": "This assessment concerns the ready-to-use Ogluo formulation and its severe-hypoglycemia indication. A real-world actual-use study was planned; that plan is not a completed result in this document.", "citations": [ { "documentId": "ema-50305", "pages": [ 108, 112 ] } ] } ], "studies": [], "remainingWork": [ "Review actual-use follow-up and separately assess other glucagon delivery systems.", "Reconcile pediatric age groups, study timing and real emergency outcomes with current formulation-specific labels." ], "versionPath": "/peptides/glucagon/official-documents/versions/1/", "counts": { "inventoried": 1, "sectionsReviewed": 1, "notReviewed": 0, "unavailable": 0 } }, { "peptideSlug": "semaglutide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "discovery": { "url": "https://www.ema.europa.eu/en/documents/report/documents-output-json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439", "scope": "One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading." }, "documents": [ { "id": "ema-14075", "title": "Ozempic : EPAR - Public assessment report", "url": "https://www.ema.europa.eu/en/documents/assessment-report/ozempic-epar-public-assessment-report_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2018-02-21", "feedApplicationId": "EMEA/H/C/004174", "status": "sections-reviewed", "note": "Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.", "reading": { "product": "Ozempic", "applicationId": "EMEA/H/C/004174", "documentDate": "2017-12-14", "retrievedAt": "2026-09-19", "payloadSha256": "71a57c0097238e05c51a99f58ace2036ea8d91ff70356300bc41573892a60a84", "pageCount": 156, "identityPages": [ 1 ], "readPages": [ 1, 147, 149, 154, 155 ], "scope": "Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal." } } ], "findings": [ { "heading": "The initial Ozempic review concerns type 2 diabetes", "text": "EMA’s December 2017 assessment reports improvements in HbA1c and weight in controlled trials and a separate cardiovascular trial in people at high cardiovascular risk. It does not summarize later obesity, kidney or other indication-specific programs.", "citations": [ { "documentId": "ema-14075", "pages": [ 154, 155 ] } ] }, { "heading": "Cardiovascular outcomes were not uniformly improved", "text": "The review described benefit on some cardiovascular outcomes but neutral findings for cardiovascular death and all-cause death. It also cautioned against extrapolating the two-year high-risk trial to lower-risk populations.", "citations": [ { "documentId": "ema-14075", "pages": [ 154, 155 ] } ] }, { "heading": "Retinopathy was an observed safety signal", "text": "Serious retinopathy complications were more frequent with semaglutide in the reviewed trial, especially among participants with pre-existing retinopathy receiving insulin. EMA treated the mechanism as uncertain rather than proving a single explanation.", "citations": [ { "documentId": "ema-14075", "pages": [ 147, 149, 155 ] } ] }, { "heading": "Harms and duration matter alongside average benefit", "text": "Gastrointestinal adverse effects were frequent and clinically relevant. EMA also noted that two years is relatively short for chronic diabetes treatment, supporting longer follow-up rather than assuming that trial results settle every long-term risk.", "citations": [ { "documentId": "ema-14075", "pages": [ 154, 155 ] } ] } ], "studies": [], "remainingWork": [ "Review Wegovy obesity, subsequent cardiovascular and kidney assessments as distinct indication-specific programs.", "Reconcile later retinopathy evidence and formulation-specific safety updates with the original Ozempic assessment." ], "versionPath": "/peptides/semaglutide/official-documents/versions/1/", "counts": { "inventoried": 1, "sectionsReviewed": 1, "notReviewed": 0, "unavailable": 0 } }, { "peptideSlug": "tirzepatide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "discovery": { "url": "https://www.ema.europa.eu/en/documents/report/documents-output-json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439", "scope": "One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading." }, "documents": [ { "id": "ema-56782", "title": "Mounjaro : EPAR - Public assessment report", "url": "https://www.ema.europa.eu/en/documents/assessment-report/mounjaro-epar-public-assessment-report_en.pdf", "authority": "EMA", "sourceUpdatedAt": "2022-11-25", "feedApplicationId": "EMEA/H/C/005620", "status": "sections-reviewed", "note": "Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.", "reading": { "product": "Mounjaro", "applicationId": "EMEA/H/C/005620", "documentDate": "2022-07-21", "retrievedAt": "2026-09-19", "payloadSha256": "dec7c5c0d0692f96f66dff032922f375b9aecb73948c663c4df4bb5d80e10283", "pageCount": 212, "identityPages": [ 1 ], "readPages": [ 1, 203, 204, 205, 211 ], "scope": "Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal." } } ], "findings": [ { "heading": "The five trials had different comparisons", "text": "EMA’s July 2022 assessment covers SURPASS-1 through SURPASS-5 in type 2 diabetes. Placebo comparisons were blinded, while several active-comparator trials were open-label and used different background therapies.", "citations": [ { "documentId": "ema-56782", "pages": [ 203 ] } ] }, { "heading": "An effect estimate depends on what happened after discontinuation", "text": "The review distinguishes an analysis including treatment changes and nonadherence from an efficacy analysis assuming intended treatment without rescue. These address different questions and should not be merged into one headline estimate.", "citations": [ { "documentId": "ema-56782", "pages": [ 204 ] } ] }, { "heading": "Comparisons apply to the regimens actually studied", "text": "The assessment found greater glycemic and weight improvements than its studied comparators, including the then-studied semaglutide regimen. This does not establish superiority over every formulation, regimen, population or later trial.", "citations": [ { "documentId": "ema-56782", "pages": [ 203, 204 ] } ] }, { "heading": "Important populations were sparsely represented", "text": "EMA noted limited clinical evidence in severe kidney or liver impairment, alongside gastrointestinal adverse effects and treatment discontinuations. This original diabetes assessment is distinct from later weight-management and other indication reviews.", "citations": [ { "documentId": "ema-56782", "pages": [ 205, 211 ] } ] } ], "studies": [], "remainingWork": [ "Review later weight-management, sleep-apnea and cardiovascular-outcomes assessments separately from SURPASS.", "Appraise trial publications and statistical plans with their treatment-policy and efficacy estimands preserved." ], "versionPath": "/peptides/tirzepatide/official-documents/versions/1/", "counts": { "inventoried": 1, "sectionsReviewed": 1, "notReviewed": 0, "unavailable": 0 } }, { "peptideSlug": "bremelanotide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "discovery": { "url": "https://www.ema.europa.eu/en/documents/report/documents-output-json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439", "scope": "One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading." }, "documents": [ { "id": "fda-bremelanotide-review-2019", "title": "Vyleesi: FDA selected application review", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210557Orig1s000MultidisciplineR.pdf", "authority": "FDA", "sourceUpdatedAt": "2019-06-21", "feedApplicationId": null, "status": "sections-reviewed", "note": "Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.", "reading": { "product": "Vyleesi", "applicationId": "NDA 210557", "documentDate": "2019-06-21", "retrievedAt": "2026-09-19", "payloadSha256": "065ab49b8fbc93c5bbdcff0604d966f2256f177e644b01b82b169a1e74e0e564", "pageCount": 539, "identityPages": [ 5 ], "readPages": [ 5, 22, 23, 26 ], "scope": "Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal." } } ], "findings": [ { "heading": "Desire and distress were the supported outcomes", "text": "FDA’s 2019 review describes two six-month placebo-controlled trials in premenopausal women with acquired, generalized hypoactive sexual desire disorder. The supported outcomes were modest improvements in reported desire and associated distress.", "citations": [ { "documentId": "fda-bremelanotide-review-2019", "pages": [ 22, 26 ] } ] }, { "heading": "A related endpoint did not improve", "text": "Bremelanotide did not improve the number of satisfying sexual events, a key secondary endpoint. FDA explained why improvement on that measure was not required for this specific indication.", "citations": [ { "documentId": "fda-bremelanotide-review-2019", "pages": [ 26 ] } ] }, { "heading": "The measurement window affects interpretation", "text": "The questionnaires recalled approximately a month, while use in the trials was intermittent. FDA discussed this mismatch when interpreting patient-reported changes; the scores should not be presented as a response to every individual use.", "citations": [ { "documentId": "fda-bremelanotide-review-2019", "pages": [ 26 ] } ] }, { "heading": "The studied population limits the conclusion", "text": "FDA did not establish efficacy in postmenopausal women in this review. Blood-pressure effects, nausea and pigmentation changes were important safety issues, and limited pregnancy information led to further study requirements.", "citations": [ { "documentId": "fda-bremelanotide-review-2019", "pages": [ 23, 26 ] } ] } ], "studies": [], "remainingWork": [ "Review the pivotal publications, discontinuation patterns and later postmarketing requirements.", "Reconcile subsequent labeling and pregnancy follow-up without treating the 2019 review as current surveillance." ], "versionPath": "/peptides/bremelanotide/official-documents/versions/1/", "counts": { "inventoried": 1, "sectionsReviewed": 1, "notReviewed": 0, "unavailable": 0 } }, { "peptideSlug": "leuprolide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "discovery": { "url": "https://www.ema.europa.eu/en/documents/report/documents-output-json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439", "scope": "One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading." }, "documents": [ { "id": "fda-leuprolide-review-2021", "title": "Camcevi: FDA selected application review", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/211488Orig1s000MultidisciplineR.pdf", "authority": "FDA", "sourceUpdatedAt": "2021-05-12", "feedApplicationId": null, "status": "sections-reviewed", "note": "Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.", "reading": { "product": "Camcevi", "applicationId": "NDA 211488", "documentDate": "2021-05-12", "retrievedAt": "2026-09-19", "payloadSha256": "d115a3d1c53c53ff80dfe0b6f5cd9f6caa5d963733f45199d78bb049105f5db4", "pageCount": 167, "identityPages": [ 2 ], "readPages": [ 2, 13, 18 ], "scope": "Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal." } } ], "findings": [ { "heading": "This application relied on a formulation-specific bridge", "text": "FDA’s Camcevi review describes a 505(b)(2) application relying in part on prior findings for Lupron, with supporting clinical bridging data. It is not a new trial of every leuprolide formulation or indication.", "citations": [ { "documentId": "fda-leuprolide-review-2021", "pages": [ 13 ] } ] }, { "heading": "The pivotal study was uncontrolled", "text": "The reviewed trial enrolled 137 patients with advanced prostate cancer in a single-arm, open-label design. Without a randomized comparator, it cannot establish superiority over other androgen-deprivation treatments.", "citations": [ { "documentId": "fda-leuprolide-review-2021", "pages": [ 13 ] } ] }, { "heading": "Testosterone suppression was the primary endpoint", "text": "FDA evaluated whether testosterone suppression was achieved and maintained from day 28 through day 336. That endpoint is distinct from demonstrating longer survival or better patient-reported quality of life in this trial.", "citations": [ { "documentId": "fda-leuprolide-review-2021", "pages": [ 13, 18 ] } ] }, { "heading": "The extension was a smaller safety follow-up", "text": "An additional 30 patients continued into the safety extension after day 336. They should not be counted as an independent confirmatory trial or as long-term observations for all original participants.", "citations": [ { "documentId": "fda-leuprolide-review-2021", "pages": [ 13 ] } ] } ], "studies": [], "remainingWork": [ "Review other leuprolide formulations and indications separately from Camcevi.", "Reconcile the pivotal protocol, publication and longer follow-up before making patient-centered outcome claims." ], "versionPath": "/peptides/leuprolide/official-documents/versions/1/", "counts": { "inventoried": 1, "sectionsReviewed": 1, "notReviewed": 0, "unavailable": 0 } }, { "peptideSlug": "lanreotide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "discovery": { "url": "https://www.ema.europa.eu/en/documents/report/documents-output-json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439", "scope": "One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading." }, "documents": [ { "id": "fda-lanreotide-review-2014", "title": "Somatuline Depot: FDA selected application review", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2022/022074Orig1s011.pdf", "authority": "FDA", "sourceUpdatedAt": "2014-12-16", "feedApplicationId": null, "status": "sections-reviewed", "note": "Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.", "reading": { "product": "Somatuline Depot", "applicationId": "NDA 022074", "documentDate": "2014-12-16", "retrievedAt": "2026-09-19", "payloadSha256": "1130ab9cde9c9010cc5f49111f51bac7d096d273aef7696d05817de03fbd0a93", "pageCount": 199, "identityPages": [ 31 ], "readPages": [ 31, 32, 36, 40 ], "scope": "Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal." } } ], "findings": [ { "heading": "The tumor study measured progression-free survival", "text": "FDA’s December 2014 review describes a 204-participant, randomized, double-blind placebo-controlled trial in unresectable or metastatic, well- or moderately differentiated gastroenteropancreatic neuroendocrine tumors. The primary endpoint combined radiological progression or death.", "citations": [ { "documentId": "fda-lanreotide-review-2014", "pages": [ 32, 36 ] } ] }, { "heading": "Delayed progression did not establish longer survival", "text": "FDA found longer progression-free survival with lanreotide. Overall-survival data were immature with no apparent difference between groups at that assessment, so these outcomes should not be treated as interchangeable.", "citations": [ { "documentId": "fda-lanreotide-review-2014", "pages": [ 32 ] } ] }, { "heading": "Most participants had stable disease before entry", "text": "Nearly all participants had stable disease before randomization. That population limits extrapolation of the result to every rapidly progressing tumor or tumor subtype.", "citations": [ { "documentId": "fda-lanreotide-review-2014", "pages": [ 32 ] } ] }, { "heading": "The safety account is indication-specific", "text": "The reviewed tumor study reported glucose abnormalities, bradycardia and gallbladder findings. Its exposure and population differ from the earlier acromegaly program; this supplement is not a complete review of every lanreotide use.", "citations": [ { "documentId": "fda-lanreotide-review-2014", "pages": [ 40 ] } ] } ], "studies": [], "remainingWork": [ "Review the original acromegaly and later carcinoid-syndrome assessments separately.", "Appraise CLARINET extension and survival follow-up, preserving crossover and enrollment limitations." ], "versionPath": "/peptides/lanreotide/official-documents/versions/1/", "counts": { "inventoried": 1, "sectionsReviewed": 1, "notReviewed": 0, "unavailable": 0 } }, { "peptideSlug": "octreotide", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "discovery": { "url": "https://www.ema.europa.eu/en/documents/report/documents-output-json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439", "scope": "One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading." }, "documents": [ { "id": "fda-octreotide-review-2020", "title": "Mycapssa: FDA selected application review", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/208232Orig1s000SumR.pdf", "authority": "FDA", "sourceUpdatedAt": "2020-06-23", "feedApplicationId": null, "status": "sections-reviewed", "note": "Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.", "reading": { "product": "Mycapssa", "applicationId": "NDA 208232", "documentDate": "2020-06-23", "retrievedAt": "2026-09-19", "payloadSha256": "5d3d903a45a1716927050991fc46b70790be4a156694e41988ce9e15b9b5c94c", "pageCount": 32, "identityPages": [ 2 ], "readPages": [ 2, 3, 4, 5, 6 ], "scope": "Selected identity, clinical-summary and benefit-risk sections only; this is not a full-document or all-indication appraisal." } } ], "findings": [ { "heading": "The oral formulation was tested for maintenance", "text": "FDA’s 2020 review evaluated oral octreotide in people whose acromegaly was already controlled with injectable octreotide or lanreotide. The randomized placebo-controlled study tested maintenance of biochemical control over 36 weeks.", "citations": [ { "documentId": "fda-octreotide-review-2020", "pages": [ 3, 4 ] } ] }, { "heading": "The endpoint was biochemical control", "text": "More participants maintained the specified IGF-1 threshold with oral octreotide than placebo. IGF-1 and growth-hormone measures are distinct from directly measuring survival or every symptom in this trial.", "citations": [ { "documentId": "fda-octreotide-review-2020", "pages": [ 3, 5 ] } ] }, { "heading": "Prior response defined who was studied", "text": "The review restricted its conclusion to people who had responded to and tolerated octreotide or lanreotide. No participants previously controlled with pasireotide were enrolled, leaving that switch unanswered.", "citations": [ { "documentId": "fda-octreotide-review-2020", "pages": [ 4, 5 ] } ] }, { "heading": "Oral administration did not remove class-related harms", "text": "Gastrointestinal, gallbladder and glucose abnormalities were reported. FDA found the safety pattern consistent with the somatostatin-analogue class; that does not mean the oral formulation was free of adverse effects.", "citations": [ { "documentId": "fda-octreotide-review-2020", "pages": [ 4, 6 ] } ] } ], "studies": [], "remainingWork": [ "Review the injectable octreotide programs separately from oral maintenance therapy.", "Appraise oral extension reports and later comparative studies with prior-response selection preserved." ], "versionPath": "/peptides/octreotide/official-documents/versions/1/", "counts": { "inventoried": 1, "sectionsReviewed": 1, "notReviewed": 0, "unavailable": 0 } }, { "peptideSlug": "insulin-glargine-aldy", "version": 1, "publishedAt": "2026-09-19", "reviewedAt": "2026-09-19", "discovery": { "url": "https://www.ema.europa.eu/en/documents/report/documents-output-json-report_en.json", "retrievedAt": "2026-09-15", "payloadSha256": "c0c68d7d77783e0355cbc75bdd04772e9acc163236fc68abcd794477c4c3d439", "scope": "One selected official document from the retained EMA document inventory or an independently retrieved FDA application package. Other formulations, later variations, national records and the wider source inventory remain outside this reading." }, "documents": [ { "id": "fda-langlara-approval-2026", "title": "Langlara: FDA approval letter", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761412Orig1s000ltr.pdf", "authority": "FDA", "sourceUpdatedAt": "2026-04-29", "feedApplicationId": null, "status": "sections-reviewed", "note": "Application identity and document date were checked in the PDF, independently of the URL year or candidate feed association.", "reading": { "product": "Langlara", "applicationId": "BLA 761412", "documentDate": "2026-04-29", "retrievedAt": "2026-09-19", "payloadSha256": "ef59f1e69d9b3f9045e067d76c1c602dac9f20ab90520c2e7535832db50ab5dc", "pageCount": 6, "identityPages": [ 1, 6 ], "readPages": [ 1, 6 ], "scope": "Approval-letter identity, licensing language and signature date only. This is not a clinical-review or trial-level appraisal." } } ], "findings": [ { "heading": "The approval is tied to an exact biosimilar identity", "text": "FDA’s April 2026 letter licenses Langlara, insulin glargine-aldy, under BLA 761412. The reference product is US-Lantus; this should not be confused with other insulin-glargine suffixes or applications.", "citations": [ { "documentId": "fda-langlara-approval-2026", "pages": [ 1 ] } ] }, { "heading": "Biosimilarity and interchangeability are product-specific findings", "text": "The letter addresses the specified Langlara presentation as biosimilar to and interchangeable with the specified US-Lantus presentation. It is not a ranking of all insulin products or permission to treat their presentations as identical.", "citations": [ { "documentId": "fda-langlara-approval-2026", "pages": [ 1 ] } ] }, { "heading": "The letter and clinical-trial evidence serve different purposes", "text": "This approval letter records a licensing decision and the glycemic-control indication. It does not supply a trial-level comparative efficacy analysis; the separate label account explains which insulin-glargine studies its label summarizes.", "citations": [ { "documentId": "fda-langlara-approval-2026", "pages": [ 1 ] } ] } ], "studies": [], "remainingWork": [ "Locate and read the product-specific biosimilarity and interchangeability review behind BLA 761412.", "Reconcile current branded and unbranded labeling without assigning evidence from a different insulin-glargine suffix." ], "versionPath": "/peptides/insulin-glargine-aldy/official-documents/versions/1/", "counts": { "inventoried": 1, "sectionsReviewed": 1, "notReviewed": 0, "unavailable": 0 } } ] }