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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 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 Food and Drug Administration approved a new Alzheimer’s drug from Eli Lilly that has been shown in clinical trials to modestly slow a decline in memory and thinking abilities in people with ...
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.
"We really are pleased that the advisory committee recognized donanemab's strong positive benefit risk," Dawn Brooks, Lilly's development leader for donanemab, said in an interview after the vote.
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 ...
In Lilly’s studies, the death rate from ARIA was about 2.3% in those receiving donanemab compared to 1.9% in the placebo group after three years. What the committee found
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 ...