Swedish research-based biopharma company BioArctic AB (STO:BIOA-B) and its Japanese partner Eisai Co Ltd (TYO:4523) announced on Monday that Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Leqembi (lecanemab).

This authorisation covers the treatment of adults with mild cognitive impairment or mild dementia due to Alzheimer's disease who are ApoE ε4 non-carriers or heterozygotes with confirmed amyloid pathology. Leqembi is the first therapy approved in Canada targeting an underlying cause of early Alzheimer's disease.

The approval is based on Eisai's global Phase 3 Clarity AD study, which met its primary and all key secondary endpoints with statistically significant results. The conditional approval requires additional data to confirm clinical benefit, with Eisai planning to submit real-world evidence.

Leqembi, developed from BioArctic's antibody research, binds to soluble and insoluble amyloid-beta aggregates, reducing both protofibrils and plaques. It has been approved in 51 countries including the United States, Japan, China, and across Europe, with applications under review in nine more.

Under a long-term partnership, Eisai leads clinical development and commercialisation, while BioArctic holds rights to commercialise Leqembi in the Nordic region. The two companies are preparing for a joint market launch in those countries.