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- A panel of FDA advisors voted unanaimously that Eli Lilly’s (NYSE:LLY) donanemab is effective in treating Alzheimer’s disease in a population of patients with mild cognitive impairment and mild dementia.
- The vote was 11-0.
- In briefing documents, FDA scientists suggested a safety warning for donanemab due to suspected brain hemorrhages, manifested as amyloid-related imaging abnormalities (ARIA).
- The meeting of the Peripheral and Central Nervous System Advisory Committee is still going on. They have yet to vote on another question asking if the benefits of donanemab outweigh the risks.