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As it did for Leqembi, the FDA placed its strongest "boxed" safety warning on donanemab's prescribing label, flagging the risk of potentially dangerous brain swelling and bleeding.
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 ...
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 ...
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 US Food and Drug Administration (FDA) approved Kisunla for the treatment of Alzheimer’s disease in July. Breaking News: The FDA has granted approval of Kisunla (donanemab) for the treatment ...
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 told a committee of FDA advisers in June that late-stage clinical research data showed “highly meaningful results” for people who took donanemab, with about 35% lower risk of progression ...