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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 ...
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 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 ...
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.
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 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 PDUFA date serves as a good first approximation of when a final decision on drug approval can be expected. Sponsors frequently publish PDUFA dates for their pending applications, [1] and while there is no official list of PDUFA dates, [10] several websites collect PDUFA dates from press announcements in a calendar form. [11]
The Food and Drug Administration has pushed back its approval decision deadline for Eli Lilly’s experimental Alzheimer’s drug donanemab. Lilly applied to the FDA for approval of the drug in ...