On 25 October 2025, Health Canada approved lecanemab (brand name Leqembi) for use in Canada. This is the first medication in more than a decade—and the first in Canada with a mechanism of action targeting the underlying biology of Alzheimer’s disease.
Lecanemab is indicated for people diagnosed with early-stage Alzheimer’s disease or mild cognitive impairment due to Alzheimer’s, and who have evidence of amyloid-plaque accumulation. The Alzheimer Society of Canada explains that while the treatment is a breakthrough, it is not a cure and its uptake may be gradual due to requirements such as specialized diagnostics (e.g., PET scans or lumbar-puncture tests) and intravenous infusions every two weeks.
Health Canada’s approval follows similar earlier approvals in the U.S. and other jurisdictions. Canadian patient-advocacy groups have welcomed the decision, emphasizing that earlier diagnosis becomes even more important when such treatments are available. At the same time, they caution that access barriers remain significant—public-plan coverage may require more than two years to shader in, and private plans may take even longer.
The clinical trial data show that lecanemab slowed cognitive decline by approximately 27 % over an 18-month period compared with placebo in patients with early Alzheimer’s and confirmed amyloid pathology. Side-effects include risks of brain swelling or bleeding in some patients, especially those with two copies of the APOE ε4 gene. Eligibility criteria therefore exclude certain high-risk individuals, such as APOE ε4 homozygotes.
Main Points
- Health Canada has authorized lecanemab (Leqembi®) for early-stage Alzheimer’s disease—marking a significant milestone in dementia treatment in Canada.
- The drug represents a disease-modifying treatment (targeting amyloid plaques) rather than only symptom-management.
- Uptake will depend on confirmatory diagnostics (e.g., biomarker tests), eligibility restrictions (early stage only), and infrastructure (infusion facilities, monitoring).
- Despite approval, widespread access will likely not be immediate: public-plan listing may take over two years and private-plan uptake may lag.
- The treatment is not a cure, and benefits—while statistically significant—are modest and specific to early-stage patients.
- Side-effects and eligibility constraints mean it’s not suitable for everyone with Alzheimer’s.
Projections & What It Means for the Future
Diagnosis and care system preparedness: Canada’s healthcare system will need to expand capacity for early diagnosis (e.g., PET scans, lumbar punctures, biomarker testing) and create infusion-therapy units. Regions with limited resources may lag in access, which may exacerbate health-equity gaps.
Health-economics and coverage debates: Given the high cost of such therapies and specialized monitoring, provincial and territorial health plans will face pressure to evaluate cost-benefit, negotiate pricing, and decide coverage eligibility. Earlier access in private plans may widen disparity between insured and non-insured populations.
Research momentum and treatment landscape: Approval of lecanemab may catalyze further research into Alzheimer’s therapies—including other monoclonal antibodies and anti-tau treatments—and shift public and private investment. We may see a wave of drug approvals and expanded biomarker-based diagnosis over the next several years.
Patient and caregiver expectations: The approval may raise hope among patients and families—but managing expectations is key. Because benefits are modest and only apply in early disease, education campaigns will be necessary to avoid misinformation or unrealistic hopes.
Equity and access concerns: Regions with fewer specialist neurologists, less diagnostic infrastructure or weaker home-care networks may struggle to provide timely access. This risks creating two-tier treatment access (urban vs rural, well-insured vs under-insured).
Policy and health-system transformation: Health-Canada’s move may spur provincial reform around dementia care pathways, early-detection programs and integration of neurology, geriatrics and primary-care services. Policymakers may also prioritize funding for supportive care and non-drug interventions while disease-modifying treatments scale up.
In summary: Health Canada’s approval of lecanemab is a landmark step in Alzheimer’s-disease treatment, but it brings complex implications around access, system readiness and realistic outcomes. The broader shift to biologically targeted therapies may reshape how dementia is diagnosed and treated—but equitable delivery and measuring real-world benefit will be critical.
References
- “Health Canada approves 1st drug to slow Alzheimer’s,” Global News, Oct 2025. https://globalnews.ca/news/11500367/health-canada-approves-alzheimers-treatment/
- Alzheimer Society of Canada: “Health Canada Approves Lecanemab (Leqembi®) for the Treatment of Early Alzheimer’s Disease.”
- Biogen press release: “Health Canada Grants Authorization for LEQEMBI® (lecanemab) for the Treatment of Early Alzheimer’s Disease.”
