Search results
Results from the WOW.Com Content Network
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.
Like Eisai and Biogen's rival drug Leqembi, which was approved a year ago, donanemab is designed to clear an Alzheimer's-related protein called beta amyloid from the brain.
Lilly's donanemab was declined accelerated approval by the FDA in January 2023, and on March 8, the agency said it would hold a meeting of its advisers to discuss the drug, further delaying its ...
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.
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 Leqembi.
Editor’s Note: “Dr. Sanjay Gupta Reports: The Last Alzheimer’s Patient” airs at 8 p.m. ET Sunday, July 7, on CNN. The US Food and Drug Administration on Tuesday approved donanemab, a ...
An FDA analysis of trial data for Eli Lilly's experimental Alzheimer's drug donanemab released on Thursday revealed no red flags, but raised questions about safety of the treatment for patients ...