Abaloparatide official document review · version 1
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Inside the official reviews
Reviewed 2026-09-16 · Preserved version 1
Why do official accounts report different fracture results?
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. EMA PDF pp. 180, 181, 182 ↗FDA PDF pp. 17 ↗
More findings, study links and document coverage
What did EMA conclude, and what remained uncertain?
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. EMA PDF pp. 188, 189, 190 ↗
Which studies overlap?
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. EMA PDF pp. 180, 181 ↗
Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.
Matched study identities
Protocol identifiers were matched to ClinicalTrials.gov records. This does not count extensions as new independent trials.
- BA058-05-003 · NCT01343004 ↗ · EMA PDF pp. 180 ↗
- BA058-05-005 · NCT01657162 ↗ · EMA PDF pp. 181 ↗
Document coverage
Selected sections read in 2 of 10 inventoried documents; 7 not yet reviewed; 1 unavailable. Reading selected sections does not establish complete appraisal of a document.
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. EMA inventory source ↗
Inspect documents, application identities and source pins
Page references use one-based PDF file pages, which can differ from printed page numbers. Candidate feed associations are not verified application identities.
Eladynos : EPAR - Public assessment report ↗
Selected sections reviewed · ema-57153 · Document/feed date: 2022-12-22
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. The older refusal remains separate.
Verified: Eladynos · EMEA/H/C/005928 · Document dated 2022-10-13. Identity checked on PDF pp. 1.
Identity and procedure history; benefit-risk discussion, evidence limitations and recommendations, pages 180–190. Other sections have not been appraised.
Retrieved 2026-09-15. Read PDF pages: 1, 2, 3, 4, 8, 9, 10, 180, 181, 182, 183, 184, 185, 186, 187, 188, 189, 190 of 191. SHA-256:
cdf20ac8d4283bcbad09a4199babba6e781914feddc05cd40ea20e587759c3f7.Feed-listed application (not a verified association): EMEA/H/C/004157.
Tymlos: FDA clinical review (2016; 2017 approval package) ↗
Selected sections reviewed · fda-abaloparatide-fda-2017 · Document/feed date: 2016-12-08
Historical approval-package review; later labels and postmarketing outcomes require separate reconciliation.
Verified: Tymlos · NDA 208743 · Document dated 2016-12-08. Identity checked on PDF pp. 1, 2.
Selected identity, benefit-risk, clinical evidence and limitations sections; not a complete dossier appraisal.
Retrieved 2026-09-16. Read PDF pages: 1, 2, 3, 4, 5, 17, 35, 126, 127 of 190. SHA-256:
bf0cbf94a3346e43b2ce494a874baaff0dd57e918f09718955142b8266ea9287.Eladynos : EPAR - Refusal public assessment report ↗
Not yet reviewed · ema-43729 · Document/feed date: 2019-02-14
Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/004157.
CHMP summary of positive opinion for Eladynos ↗
Not yet reviewed · ema-56405 · Document/feed date: 2022-10-13
Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.
Eladynos : EPAR - Medicine overview ↗
Not yet reviewed · ema-57149 · Document/feed date: 2022-12-22
Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/004157.
Questions and answers on refusal of the marketing authorisation for Eladynos (abaloparatide) ↗
Not yet reviewed · ema-21920 · Document/feed date: 2018-07-27
Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.
Eladynos : EPAR - All authorised presentations ↗
Not yet reviewed · ema-57152 · Document/feed date: 2023-12-06
Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/004157.
Eladynos : EPAR - Procedural steps taken and scientific information after authorisation ↗
Not yet reviewed · ema-58737 · Document/feed date: 2024-04-12
Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/004157.
Eladynos : EPAR - Risk-management-plan ↗
Not yet reviewed · ema-57150 · Document/feed date: 2022-12-22
Discovered in the retained EMA document feed; product/application association and substantive content are not yet verified.
Feed-listed application (not a verified association): EMEA/H/C/004157.
Eladynos: EPAR - Product information ↗
Unavailable · ema-57151 · Document/feed date: 2024-04-12
PDF retrieval through the web reader returned HTTP 429 on September 16 after a backoff. No payload or internal application identity was verified; the older application number in the feed remains unconfirmed for this document.
Feed-listed application (not a verified association): EMEA/H/C/004157.
Remaining work
- 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.