Biogen and Eisai Co., Ltd announced that Health Canada has accepted a new drug submission (NDS) for LEQEMBI® (lecanemab) to treat early Alzheimer’s disease (AD) and mild AD dementia with confirmed amyloid pathology in the brain. LEQEMBI® is an investigational anti-amyloid beta protofibril antibody. The NDS is based on a Phase III study and Phase IIb clinical study which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD.
On 5 March 2023 the FDA accepted the sBLA and granted priority review for traditional approval of LEQEMBI™ (lecanemab), and the FDA is discussing the full approval on 9 June 2023.