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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 ...
In trials of Leqembi, the drug that’s already on the market, some participants also had ARIA, but it was at a lower rate than seen in the donanemab trial. Leqembi has also been tied to patient ...
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 ...
Lilly applied to the FDA for approval of the drug in July, after late-stage clinical trial data showed it slowed the progression of Alzheimer’s by 29% after 18 months, compared to a placebo.
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.
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.
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
In Lilly's large clinical trial, donanemab, given by infusion once a month, slowed progression of memory and thinking problems by 29% overall, roughly comparable to the 27% slowing seen with Leqembi.