US FDA approves monthly maintenance dosing for Biogen/Eisai Alzheimer’s drug

Published 27-01-2025, 05:38 am

Investing.com-- The U.S. Food and Drug Administration approved monthly maintenance dosing for an Alzheimer’s drug developed by Japan’s Eisai Co., Ltd. (TYO:4523) and U.S. partner Biogen (NASDAQ:BIIB), the two said on Monday.

The approval allows patients to receive a monthly dose of the drug, Leqmbi, after receiving an intravenous infusion of the drug every two weeks for 18 months, Eisai and Biogen said in a joint statement. Patients can also continue to dose once every two weeks.

Leqembi received standard FDA approval in 2023 after it showed progress in slowing cognitive decline in Alzheimer’s patients. 

Last year, a rival drug from Eli Lilly (NYSE:LLY), Kisunla, was approved by the FDA. Kisunla is administered once a month and can be stopped after substantial progress in curbing the disease. 

Both drugs target deposits of a protein called amyloid beta in the brain, which has been linked to Alzheimer’s disease. Leqembi requires maintenance dosing to prevent future amyloid buildup. 



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