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(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 ...
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 ...
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 ...
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 ...
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
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.
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 ...