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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 ...
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
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 Biotechnology Center in San Diego, Calif. Credit - Getty Images. O n July 2, the U.S. Food and Drug Administration (FDA) approved a new drug for treating Alzheimer’s disease. Donanemab, or ...
A decision on donanemab has been delayed, with the regulatory agency initially planning to make a call in July, the same time it was approved for use in the U.S., the report said.
"We really are pleased that the advisory committee recognized donanemab's strong positive benefit risk," Dawn Brooks, Lilly's development leader for donanemab, said in an interview after the vote.
Eli Lilly and Co. Executive Vice President Anne White said in a statement that the Indianapolis-based company remains confident in donanemab’s potential and will work with the FDA.