FDA accepts filing of Leqembi[®] (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of early Alzheimer’s Disease
Stockholm, Sweden, June 10, 2024 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s Supplemental Biologics License Application (sBLA) for less frequent 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. In the US, Leqembi is indicated for the treatment of Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease (collectively