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The approval for donanemab, to be sold under the brand name Kisunla, followed the recommendations of the agency's outside experts, who unanimously backed its use in patients with early Alzheimer's ...
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 ...
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 ...
Donanemab, sold under the brand name Kisunla, is a monoclonal antibody used for the treatment of Alzheimer's disease. [1] [2] Donanemab was developed by Eli Lilly and Company. [3] [4] The most common side effects include amyloid-related imaging abnormalities and headache. [2] Donanemab was approved for medical use in the United States in July 2024.
The FDA approved Kisunla, known chemically as donanemab, based on results from an 18-month study in which patients given getting the treatment declined about 22% more slowly in terms of memory and ...
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 agency’s approval was based on a late-stage clinical trial of 1,700 people that showed the drug slowed the progression of Alzheimer’s by about 35% after 18 months, compared to a placebo ...
The FDA often asks committees to review drugs that are first in their class of treatments. Donanemab, if approved, would follow Eisai’s Leqembi, which was approved last year, and Biogen’s Aduhelm.