FDA grants traditional approval for LEQEMBI® (lecanemab-irmb) for the treatment of Alzheimer’s disease
Stockholm, July 7, 2023 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the U.S. Food and Drug Administration, FDA, has approved the supplemental Biologics License Application, sBLA, supporting the traditional approval of LEQEMBI® (lecanemab-irmb) 100 mg/mL injection for intravenous use, making LEQEMBI the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline in adults with Alzheimer’s disease (AD). In conjunction with the approval the Centers for Medicare and Medicaid Services, CMS,