BioArctic AB’s partner Eisai has announced that Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for Leqembi® (lecanemab). The therapy is indicated for adult patients clinically diagnosed with mild cognitive impairment or mild dementia due to early Alzheimer’s disease (AD) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes and have confirmed amyloid pathology.
Leqembi is the first treatment in Canada for early Alzheimer’s disease that targets an underlying cause of the condition. The antibody selectively binds to soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils)—major components of Aβ plaques—thereby reducing their presence in the brain. This mechanism helps to slow disease progression and cognitive as well as functional decline in adults with Alzheimer’s.
Leqembi has now been approved in 51 countries and regions, including Japan, the United States, Europe, China, South Korea, Taiwan, and Saudi Arabia, with applications submitted in nine additional countries.
The Canadian authorization is supported by data from the global Phase 3 Clarity AD study, in which Leqembi achieved its primary and all key secondary endpoints with statistically significant results. Health Canada has granted the approval with conditions, pending additional data to confirm its long-term clinical benefits. Eisai plans to submit real-world clinical assessment data collected from patients under routine care settings.
Alzheimer’s disease remains the most prevalent form of dementia, accounting for 60–80% of all dementia cases. As of January 1, 2025, an estimated 771,000 Canadians are living with dementia—a number expected to reach 1 million by 2030 and over 1.7 million by 2050. Moreover, caregiving efforts provided by family members and friends amount to the equivalent of 290,000 full-time jobs, projected to rise to 690,000 full-time equivalents by 2050.
Leqembi is the outcome of a long-standing collaboration between BioArctic and Eisai. The antibody was originally developed by BioArctic, based on the pioneering research of Professor Lars Lannfelt, who discovered the Arctic mutation associated with Alzheimer’s disease. Eisai is responsible for the clinical development, regulatory filings, and global commercialization of Leqembi, while BioArctic retains rights to commercialize the therapy in the Nordic region in partnership with Eisai. Both companies are currently preparing for a joint launch in that market.