Submission of Leqembi® (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of early Alzheimer’s disease to the U.S. FDA completed
Stockholm, Sweden, April 1, 2024 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Eisai has submitted a supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: Leqembi®) intravenous (IV) maintenance dosing to the U.S. Food and Drug Administration (FDA). 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).As part of the monthly IV maintenance regimen, the patients who have completed the