FDA Advisory Committee votes unanimously to confirm clinical benefit of LEQEMBI® (lecanemab-irmb) for the treatment of early Alzheimer’s disease
Stockholm, June 10, 2023 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted unanimously that the data from Eisai’s Phase 3 Clarity AD clinical trial confirms the clinical benefit of LEQEMBI® (lecanemab-irmb) 100 mg/mL intravenous injection for the treatment of Alzheimer’s disease (AD). LEQEMBI received Accelerated approval from the FDA for the treatment of early Alzheimer’s disease on January 6, 2023. The PDUFA action date for traditional