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Lilly's donanemab was declined accelerated approval by the FDA in January 2023, and on March 8, the agency said it would hold a meeting of its advisers to discuss the drug, further delaying its ...
"We really are pleased that the advisory committee recognized donanemab's strong positive benefit risk," Dawn Brooks, Lilly's development leader for donanemab, said in an interview after the vote.
The FDA's decision came as a surprise to company officials and many Alzheimer's experts, who had expected a full approval for Lilly's drug donanemab this month based on clinical trial data last ...
Lilly applied to the FDA for approval of the drug in July, after late-stage clinical trial data showed it slowed the progression of Alzheimer’s by 29% after 18 months, compared to a placebo.
Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ-3, studying donanemab for the prevention of Alzheimer’s disease. Price Action: LLY shares are up 0.88% ...
Eli Lilly and Co. Executive Vice President Anne White said in a statement that the Indianapolis-based company remains confident in donanemab’s potential and will work with the FDA.
It’s called donanemab, a drug from pharmaceutical giant Eli Lilly. If the FDA approves donanemab, it could come later this year. But that doesn’t guarantee that Medicare will cover it either.
An FDA panel voted 11-0 Monday to recommend the use of Eli Lilly's (LLY) early-stage Alzheimer's treatment, known as donanemab.. The monoclonal antibody drug, delivered through an IV monthly for ...