FDA approves LEQEMBI™ (lecanemab-irmb) under the Accelerated Approval pathway for the treatment of Alzheimer’s disease
Stockholm, January 6, 2023 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that under the Accelerated Approval pathway the U.S. Food and Drug Administration (FDA) has approved lecanemab-irmb[1] (Brand Name in the U.S.: LEQEMBI™) 100 mg/mL injection for intravenous use, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (“protofibrils[2]”) and insoluble forms of amyloid beta (Aβ) for the treatment of Alzheimer’s disease (AD). The accelerated approval is based on Phase 2b data in early AD patients which demonstrated