Health Canada accepts Leqembi filing for review

Medicines regulator Health Canada has accepted a New Drug Submission (NDS), submitted by Japan’s Eisai (TYO: 4523) and US biotech Biogen (Nasdaq: BIIB), for Leqembi (lecanemab), an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain.

The US Food and Drug Administration (FDA) in January this year granted accelerate approval for their  Alzheimer’s disease drug Leqembi.

The NDS is based on the results of the Phase III Clarity AD study and Phase IIb clinical study (Study 201), which demonstrated the lecanemab treatment showed a reduction of clinical decline in early AD. Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.