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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 ...
The US Food and Drug Administration on Tuesday approved donanemab, a monoclonal antibody designed to slow the progression of early symptomatic Alzheimer’s disease.
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'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 ...
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 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 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 ...