Tesamorelin official document review · version 1
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Inside the official reviews
Reviewed 2026-09-19 · Preserved version 1
The pivotal endpoint measured abdominal fat
FDA’s 2010 assessment describes two 26-week randomized, placebo-controlled trials in HIV-associated lipodystrophy. Their primary endpoint was CT-measured visceral abdominal fat, not cardiovascular events or survival. FDA PDF pp. 3, 7 ↗
More findings, study links and document coverage
Fat reduction did not establish cardiovascular benefit
The review explicitly separates reduced visceral fat from demonstrated cardiovascular benefit. Lipid and body-image results were inconsistent across the two trials, and the body-image instrument had validity concerns. FDA PDF pp. 3, 8, 9 ↗
The extension shows a limit to persistence
Participants switched from tesamorelin to placebo accumulated visceral fat again toward baseline during follow-up. The extension’s switching and selection rules mean it should not be counted as an independent replication of the original trials. FDA PDF pp. 7, 8 ↗
Safety interpretation requires the studied population
The review identifies glucose intolerance, elevated IGF-1 and hypersensitivity concerns. Patients receiving drug treatment for type 2 diabetes were excluded, limiting extrapolation to that broader population. This is a historical assessment, not the current formulation label. FDA PDF pp. 10, 11, 12 ↗
Read the separate U.S. label account → Label version and indication scope are preserved there; these agency reviews describe their own dated evidence.
Document coverage
Selected sections read in 1 of 5 inventoried documents; 4 not yet reviewed. Reading selected sections does not establish complete appraisal of a document.
Selected English EMA PDFs from the retained September 15, 2026 title-matched document feed, plus independently retrieved FDA approval-package documents where listed. Candidate entries are not verified product/application matches. This is a bounded inventory, not a complete FDA, national or worldwide source search. 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.
Egrifta: FDA 2010 selected approval-package clinical review ↗
Selected sections reviewed · fda-egrifta-summary-2010 · Document/feed date: 2010-11-05
Independently retrieved FDA approval-package PDF. The displayed date belongs to the selected review, not the entire compilation or a current label.
Verified: Egrifta · NDA 022505 · Document dated 2010-11-05. Identity checked on PDF pp. 2.
Identity and selected clinical design, efficacy, safety and benefit-risk sections only. One-based PDF file pages; unlisted pages have not been appraised. The date identifies the selected review within any compiled approval package.
Retrieved 2026-09-19. Read PDF pages: 1, 2, 3, 4, 6, 7, 8, 9, 10, 11, 12 of 20. SHA-256:
1ba0756ca76e7a8f365d85b1b58c53acf934862ee6f314addda0082f92f88dc1.Questions and answers on the withdrawal of the marketing authorisation application for Egrifta (tesamorelin) ↗
Not yet reviewed · ema-13891 · Document/feed date: 2012-07-18
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Ferrer Internacional, S.A. withdraws its marketing authorisation application for Egrifta (tesamorelin) ↗
Not yet reviewed · ema-32433 · Document/feed date: 2012-06-26
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Withdrawal assessment report for Egrifta ↗
Not yet reviewed · ema-32484 · Document/feed date: 2012-10-23
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Withdrawal letter: Egrifta (tesamorelin) ↗
Not yet reviewed · ema-7574 · Document/feed date: 2012-07-18
Title-matched candidate in the retained EMA feed; product/application association and substantive content are not yet verified.
Remaining work
- Reconcile the historical NDA with subsequent biologics licensing and formulation-specific labels.
- Appraise later HIV-associated fatty-liver studies separately from the original abdominal-fat endpoint.