TOKYO and CAMBRIDGE, Mass., June 10, 2024 - (JCN Newswire) - Eisai Co., Ltd.

FDA Accepts Eisai's Filing of LEQEMBI Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease. and Biogen Inc. announced today that that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI) intravenous (IV) maintenance dosing. A Prescription Drug User Fee Act (PDUFA) action date is set for January 25, 2025. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively referred to as early AD).