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Like Eisai and Biogen's rival drug Leqembi, which was approved a year ago, donanemab is designed to clear an Alzheimer's-related protein called beta amyloid from the brain.
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 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 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 ...
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 ...
Jefferies analyst Michael Yee said in a note to clients that the vote "sets up an eventual FDA approval," adding that having two players on the market would be a good thing longer-term.
The FDA postponed its original decision on donanemab, which was scheduled for late last year, because it wanted to see more safety data on the medication. After Lilly provided additional ...