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August 25, 2024 at 2:00 AM ... early Alzheimer’s disease in phase 3 clinical trials, and have received FDA approval. ... lecanemab and donanemab approval for administration via intravenous ...
In Lilly's large clinical trial, donanemab, given by infusion once a month, slowed progression of memory and thinking problems by 29% overall, roughly comparable to the 27% slowing seen with ...
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 applied to the FDA for approval of the drug in July, after late-stage clinical trial data showed it slowed the progression of Alzheimer’s by 29% after 18 months, compared to a placebo.
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 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.
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 ...
— NICE (@NICEComms) August 22, 2024 Three deaths were reported among the people receiving donanemab during the trial which were considered “treatment related”, according to the 2023 paper.