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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 ...
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.
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 ...
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'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 ...
Jefferies analyst Michael Yee said in a note to clients that the vote "sets up an eventual FDA approval," adding that having two players on the market would be a good thing longer-term.
Romosozumab, sold under the brand name Evenity (/ ɪ ˈ v ɛ n ɪ t i / ih-VENN-ih-tee or with the pin-pen merger, / ɪ ˈ v ɪ n ɪ t i / ih-VINN-ih-tee), is a medication used to treat osteoporosis. [ 7 ] [ 8 ] It has been found to decrease the risk of fractures of the spine .