FDA Delays Approval of Eli Lilly's Alzheimer's Drug, Stock Dips
TL;DR Summary
The FDA has delayed its decision on Eli Lilly's experimental Alzheimer's treatment, donanemab, and plans to convene an advisory meeting to further review its safety and efficacy, reflecting the high stakes of developing treatments for Alzheimer's. The drug significantly slowed Alzheimer's progression in a late-stage trial, but carries safety concerns related to brain swelling and bleeding. This setback comes as Eli Lilly races to compete with Biogen and Eisai, who won approval for their Alzheimer's treatment, Leqembi, last year. Eli Lilly expressed confidence in donanemab's potential benefits and will work with the FDA and stakeholders to address concerns.
Topics:business#advisory-panel#alzheimers#donanemab#eli-lilly#fda#healthcare-fda-alzheimers-treatment
- Eli Lilly says FDA delays approval of Alzheimer's drug in surprise move CNBC
- 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
- F.D.A. Delays Action on Closely Watched Alzheimer's Drug The New York Times
- Eli Lilly's donanemab Alzheimer's drug delayed by FDA USA TODAY
- Eli Lilly’s stock dips as Alzheimer’s drug delayed by surprise FDA panel meeting MarketWatch
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