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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 ...
Eisai and Biogen have started submitting data to the FDA to support approval of a monthly maintenance dose to be given as an IV infusion, as well as a weekly injected version of Leqembi that ...
Donanemab is given to patients via an intravenous drip once every four weeks. Lilly has said that some patients can complete their course of treatment in as little as six months once their amyloid ...
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 was expected to approve the drug in early 2024 but delayed its approval of the drug due to questions about the adverse effects of the drug, which were as severe as brain swelling and death.
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.
The FDA accepted the request on Monday and has until January 2025 to make a decision. The timeline for Lilly's donanemab approval, initially expected by the end of the first quarter of this year ...