Health Canada Approves LEQEMBI® (lecanemab), Offering A New Treatment Option For Early Alzheimer’s Disease Patients

Eisai Co., Ltd. and Biogen Inc. announced that Health Canada has granted a Notice of Compliance with Conditions (NOC/c) for LEQEMBI® (lecanemab), a humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody. The approval allows the use of LEQEMBI for the treatment of adult patients diagnosed with mild cognitive impairment or mild dementia due to Alzheimer’s disease (early AD) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes and have confirmed amyloid pathology. 

This makes LEQEMBI the first authorized treatment in Canada for early Alzheimer’s disease that targets an underlying cause of the condition. LEQEMBI works by selectively binding to soluble Aβ aggregates (protofibrils) and insoluble Aβ aggregates (fibrils), which are key components of amyloid plaques in the brain. By reducing both Aβ protofibrils and plaques, LEQEMBI helps slow disease progression and cognitive decline in adults with Alzheimer’s disease. 

It is currently the first and only approved treatment proven to reduce the rate of disease progression while slowing both cognitive and functional decline. Globally, LEQEMBI has been approved in 51 countries and regions, including Japan, the United States, Europe, China, South Korea, Taiwan, and Saudi Arabia, with additional applications under review in nine other countries.

The approval in Canada is based on data from the large global Phase 3 Clarity AD study, where LEQEMBI achieved its primary and all key secondary endpoints with statistically significant results. The drug received market authorization with conditions, pending further evidence from ongoing studies to confirm its clinical benefits. Eisai plans to collect and submit real-world clinical assessment data from patients undergoing treatment.

Alzheimer’s disease is the most common 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 rise to approximately 1 million by 2030 and over 1.7 million by 2050. The burden on caregivers is also growing, with the annual care provided by family members and friends equivalent to 290,000 full-time jobs, projected to reach 690,000 full-time equivalents by 2050.

Eisai leads global development and regulatory submissions for lecanemab, while both Eisai and Biogen co-commercialize and co-promote the therapy. Eisai retains final decision-making authority. In Canada, Eisai Limited will oversee distribution and provide product-related information. Both companies reaffirmed their commitment to collaborating with healthcare professionals and stakeholders to advance early Alzheimer’s disease treatment and improve patient outcomes.