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Breaking News: The FDA has granted approval of Kisunla (donanemab) for the treatment of people living with early symptomatic Alzheimer’s disease. ... (EMA) rejected lecanemab in late July.
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.
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 European Medicines Agency (EMA) has already rejected Eisai Co., Ltd (OTC:ESALY) ... (MHRA) is currently reviewing donanemab, it has already approved lecanemab, ...
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 ...
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 ...
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 ...
Lilly said Japan is the second major market in which the drug has received approval, after the United States where it is sold under the same brand name Kisunla. The Alzheimer's Association ...