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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 ...
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.
Editor’s Note: “Dr. Sanjay Gupta Reports: The Last Alzheimer’s Patient” airs at 8 p.m. ET Sunday, July 7, on CNN. The US Food and Drug Administration on Tuesday approved donanemab, a ...
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.
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 FDA approved a new Alzheimer’s drug that has been shown in clinical trials to modestly slow a decline in memory and thinking abilities. ... The drug donanemab, which will be sold under the ...
The PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form.