A new era of hope for Canadians living with early Alzheimer's disease

For the first time, Canadians living with early Alzheimer’s disease have access to a treatment that targets the underlying cause of the condition. Health Canada has granted authorization with conditions for LEQEMBI® (lecanemab), developed by Eisai and Biogen for the treatment of adult patients diagnosed with mild cognitive impairment or mild dementia due to Alzheimer’s disease who have confirmed amyloid pathology.

LEQEMBI is the first therapy in Canada shown to slow cognitive and functional decline by targeting amyloid-beta (Aβ) plaques, a hallmark of Alzheimer’s disease. This approval marks a historic step forward in Alzheimer’s research and treatment, bringing new hope to the more than 771,000 Canadians currently living with dementia, a number expected to rise to over 1.7 million by 2050.

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About LEQEMBI™ and how it works

LEQEMBI is a humanized monoclonal antibody that selectively binds to soluble and insoluble forms of amyloid-beta, including toxic protofibrils that damage neurons and impair brain function. By reducing these amyloid aggregates, LEQEMBI helps slow disease progression in the early stages of Alzheimer’s.

In the large global Phase 3 Clarity AD study, LEQEMBI met its primary and all key secondary endpoints with statistically significant results. Treatment reduced clinical decline by 27% over 18 months compared to placebo, as measured by the Clinical Dementia Rating-Sum of Boxes (CDR-SB) scale. Patients also demonstrated improved ability to perform daily activities such as dressing, feeding themselves, and engaging in community life.

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What this means for Canadians

LEQEMBI’s approval marks a pivotal shift in the treatment landscape for Alzheimer’s, moving from symptom management toward addressing the biological root of the disease. While the therapy has received conditional authorization pending further data from real-world use, it represents a long-awaited step toward disease-modifying treatment in Canada.

As noted by Eisai and Biogen, the companies will continue collaborating with Canadian healthcare professionals and policymakers to support access and education around early Alzheimer’s treatment. Eisai will distribute the product in Canada and conduct ongoing data collection and information activities.

LEQEMBI is already approved in over 50 countries and regions, including the United States, Japan, Europe, China, South Korea, and Saudi Arabia. Ongoing studies such as AHEAD 3-45 and Tau NexGen continue to explore its use in preclinical and inherited forms of Alzheimer’s disease, reinforcing the global momentum toward earlier and more effective intervention.

To read the full press release details from Biogen click here.