FDA Postpones Decision on Eli Lilly's Alzheimer's Drug, Prompting Special Committee Meeting
TL;DR
The Food and Drug Administration has unexpectedly delayed the approval of the Alzheimer's drug, donanemab, which was anticipated to be approved this month. Instead, the F.D.A. will convene a panel of independent experts to evaluate the drug's safety and efficacy, surprising both Alzheimer's experts and the drug's maker, Eli Lilly and Company. The decision will postpone any potential approval until at least later this year, with the company hoping for a swift action following the advisory committee's review.
- F.D.A. Delays Action on Closely Watched Alzheimer's Drug The New York Times
- U.S. Food and Drug Administration to Convene Advisory Committee Meeting to Discuss the TRAILBLAZER-ALZ 2 Study of Donanemab | Eli Lilly and Company Investors | Eli Lilly and Company
- Lilly Alzheimer's Drug Faces Further Delays as FDA Plans Hearing Bloomberg
- In an unusual move, FDA postpones approval decision for Lilly’s Alzheimer’s drug NBC News
- Eli Lilly’s stock down 1.2% after it says FDA will hold special committee meeting to discuss safety, efficacy of its Alzheimer’s trial MarketWatch
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