Health Canada Accepts New Drug Submission for lecanemab as Treatment for Early Alzheimer’s Disease

BioArctic AB’s partner Eisai announced today that Health Canada has accepted a New Drug Submission (NDS) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease 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 binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference and simultaneously published in the New England Journal of Medicine, a peer-reviewed medical journal.

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.