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The Food and Drug Administration has pushed back its approval decision deadline for Eli Lilly’s experimental Alzheimer’s drug donanemab. Lilly applied to the FDA for approval of the drug in ...
(Reuters) -Outside advisers to the U.S. Food and Drug Administration on Monday voted unanimously that the benefits of Eli Lilly's experimental Alzheimer's treatment donanemab outweighed its risks ...
A decision on donanemab has been delayed, with the regulatory agency initially planning to make a call in July, the same time it was approved for use in the U.S., the report said.
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'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 ...
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.
Lilly’s study enrolled people ages 60 to 85 who were in early stages of Alzheimer’s. Half received once-a-month infusions of donanemab and half dummy infusions for 18 months. The study had a ...