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# FDA Panel Backs Lilly’s Alzheimer’s Drug
- URL: https://www.fdaweb.com/fda-panel-backs-lillys-alzheimers-drug/
- Published: 2024-06-10T12:00:00.000Z
- Updated: 2026-09-14T14:32:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157148

FDA’s Peripheral and Central Nervous System Advisory Committee 6/10 unanimously voted (11 to 0) to recommend the approval of Eli Lilly’s donanemab-azbt to treat Alzheimer’s disease. Panel members agreed that the clinical data and biomarker data were convincing on donanemab’s effectiveness. In discussing their vote, most members voiced concern about a lack of data for under-represented groups, such as African Americans and Hispanics, and emphasized the importance of capturing this in the future to make sure findings can be extrapolated to everyone with Alzheimer’s.

The company’s BLA was based on results from the TRAILBLAZER-ALZ 2 trial that evaluated the safety and efficacy of donanemab in patients with early symptomatic Alzheimer’s disease. FDA medical reviewers noted in a [briefing document](https://www.fda.gov/media/179166/download?ref=fdaweb.com) that the primary efficacy endpoint analysis demonstrated a statistically significant treatment effect in the donanemab treatment arm compared to placebo. They said the main safety signals associated with the use of monoclonal antibodies directed against aggregated forms of beta amyloid, including donanemab, were amyloid-related imaging abnormalities, intracerebral hemorrhage, and infusion-related reactions and hypersensitivity.

If approved, donanemab would become the second Alzheimer’s drug on the market, joining Biogen/Eisai’s Leqembi, which gained approval last year ([see story](https://fdaweb.com/login.php?sa=v&aid=D5154824&cate=&stid=%241%24a13.bM1.%24Nm9iMsCN%2FXIFLOxBJEsy3%2F&ref=fdaweb.com)).

If approved, donanemab would become the second Alzheimer’s drug on the market, joining Biogen/Eisai’s Leqembi, which gained approval last year ([see story](https://fdaweb.com/login.php?sa=v&aid=D5154824&cate=&stid=%241%24a13.bM1.%24Nm9iMsCN%2FXIFLOxBJEsy3%2F&ref=fdaweb.com)).