Health Canada accepts New Drug Submission for lecanemab as treatment for early Alzheimer’s disease
Stockholm, May 16, 2023 – BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Health Canada has accepted a New Drug Submission (NDS) for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril[1] antibody, for the treatment of early Alzheimer’s disease[2] with confirmed amyloid pathology in the brain.The NDA is based on the results of the Phase 3 Clarity AD study and the Phase 2b clinical study, which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD. Lecanemab selectively