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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 agency’s approval was based on a late-stage clinical trial of 1,700 people that showed the drug slowed the progression of Alzheimer’s by about 35% after 18 months, compared to a placebo. ...
Donanemab is given to patients via an intravenous drip once every four weeks. Lilly has said that some patients can complete their course of treatment in as little as six months once their amyloid ...
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.
A panel of brain and Alzheimer’s experts convened by the U.S. Food and Drug Administration (FDA) voted unanimously on June 10 that a new Alzheimer’s drug developed by Eli Lilly, called ...
The FDA was expected to approve the drug in early 2024 but delayed its approval of the drug due to questions about the adverse effects of the drug, which were as severe as brain swelling and death.
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 ...
The agency’s approval was based on a late-stage clinical trial of 1,700 people that showed the drug slowed the progression of Alzheimer’s by about 35% after 18 months, compared to a placebo ...