Eisai, a Japan-based partner of Sweden-based BioArctic AB(publ) (Nasdaq Stockholm: BIOA B), announced on Monday that it has received a Notice of Compliance with Conditions (NOC/c) from Health Canada for its Leqembi (lecanemab).

The product is intended for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to Alzheimer's disease (early AD) who are apolipoprotein non-carriers or heterozygotes and have confirmed amyloid pathology. It is the first treatment for early AD that is aimed at an underlying cause of the disease, to be authorised in Canada.

Leqembi has received approval based on the large global Phase three Clarity AD study. The study met its primary endpoint and all key secondary endpoints with statistically significant results. The product has authorisation in Canada with conditions, subject to the outcome of trials to verify its clinical benefit. It is the result of a long-standing partnership between BioArctic and Eisai, and the antibody was originally developed by BioArctic based on the work of Professor Lars Lannfelt and his discovery of the Arctic mutation in Alzheimer's disease.

The company is planning to submit clinical evaluation data captured from participants in real-world clinical practice.