FDA Accepts Eisai And Biogen's BLA For Subcutaneous LEQEMBI For Early Alzheimer's Disease

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(RTTNews) - Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) said that the U.S. Food and Drug Administration has accepted Eisai's Biologics License Application or BLA for lecanemab-irmb (U.S. brand name: LEQEMBI) subcutaneous autoinjector (SC-AI) for weekly maintenance dosing. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease. A Prescription Drug User Fee Act (PDUFA) action date is set for August 31, 2025.

If LEQEMBI subcutaneous maintenance dosing is approved by the FDA, LEQEMBI will be the only treatment for AD that can be administered subcutaneously at home using an autoinjector, the companies said.

LEQEMBI is approved in the U.S., Japan, China, South Korea, Hong Kong, Israel, UAE, Great Britain, Mexico, and Macau. In November 2024, the treatment received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) recommending approval.

Eisai has submitted applications for approval of lecanemab in 17 countries and regions. The US FDA accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly LEQEMBI IV maintenance dosing in June 2024 and set a PDUFA action date for January 25, 2025.

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