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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.
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.
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 ...
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 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 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 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 ...
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 ...