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FDA Releases Briefing Documents for Eli Lilly's Alzheimer's Drug Donanemab, Targeted Approval Considered

Jun 6, 2024, 02:43 PM

The FDA has released briefing documents for Eli Lilly's experimental Alzheimer's drug, donanemab. These documents include two voting questions with specific instructions from the agency. FDA staff are considering a more targeted approval for the treatment than Eli Lilly desires. A panel of outside experts will meet on Monday to vote on the safety and efficacy data for donanemab and make recommendations to the FDA. This drug is seen as a potential rival to Eisai and Biogen's Leqembi. FDA reviewers have raised questions about whether approval should be restricted to a smaller group of patients. Despite this, FDA staff have raised no major concerns about the drug. Eli Lilly shares were down 0.1% pre-market following the release of the documents.