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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 ...
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 ...
"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.
In Lilly’s studies, the death rate from ARIA was about 2.3% in those receiving donanemab compared to 1.9% in the placebo group after three years. What the committee found
A key differentiating factor for donanemab is the drug's finite dosing, which allows patients to stop taking the treatment once brain scans no longer show amyloid plaques. Lilly priced its drug at ...
Last year, the FDA approved one of the first drugs to slow Alzheimer's, a drug similar to donanemab called lecanemab or Leqembi, made by Eisai and Biogen, Tokyo and Massachusetts-based companies.
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.