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The US Food and Drug Administration (FDA) label for donanemab contains a boxed warning about amyloid-related imaging abnormalities. [1]Side effects may include infusion-related reactions, with symptoms such as flu-like symptoms, nausea, vomiting and changes in blood pressure, and hypersensitivity reactions, including anaphylaxis (severe, life-threatening allergic reaction) and angioedema ...
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 panel's recommendations are non-binding but typically followed by the U.S. Food and Drug Administration. If donanemab is approved, FDA staff said they expect its prescribing label to highlight ...
Aducanumab, sold under the brand name Aduhelm, is an anti-amyloid drug designed to treat Alzheimer's disease. It is a monoclonal antibody that targets aggregated forms (plaque) of amyloid beta (Aβ) found in the brains of people with Alzheimer's disease to reduce its buildup. [10] It was developed by Biogen and Eisai. [11] Aducanumab is given via intravenous infusion. [5] Aducanumab was ...
(Reuters) -Outside advisers to the U.S. Food and Drug Administration on Monday voted unanimously that the benefits of Eli Lilly's experimental Alzheimer's treatment donanemab outweighed its risks ...
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 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 ...
Last year, the FDA approved one of the first drugs to slow Alzheimer's, a drug similar to donanemab called lecanemab or Leqembi, made by Eisai and Biogen, Tokyo and Massachusetts-based companies.