TOKYO and CAMBRIDGE, Mass., August 31, 2026
Eisai and Biogen announced that Canada’s Drug Agency (CDA-AMC) has issued a final positive recommendation supporting public reimbursement of LEQEMBI (lecanemab) for eligible patients with early Alzheimer’s disease, including individuals living with mild cognitive impairment or mild dementia due to Alzheimer’s disease. The recommendation follows a reconsideration by CDA-AMC and represents an important step toward expanding public access to the anti-amyloid therapy in Canada. The decision does not itself establish immediate nationwide reimbursement, as the companies noted that the next stages include negotiations through the pan-Canadian Pharmaceutical Alliance (pCPA) followed by individual reimbursement decisions by provincial and territorial public drug plans. The development is particularly relevant as Canada continues to face a growing dementia burden, with more than 770,000 people estimated to be living with dementia in 2025 and the number projected to reach approximately 1.7 million by 2050.
LEQEMBI Targets Amyloid-Beta Protofibrils
LEQEMBI (lecanemab) is a humanized IgG1 monoclonal antibody developed to target aggregated soluble amyloid-beta (Aβ) protofibrils and insoluble forms of Aβ associated with Alzheimer’s disease. The therapy is being positioned for patients in the early stages of Alzheimer’s disease, where disease-modifying treatment is intended to address underlying pathology rather than solely manage symptoms. The Canadian reimbursement recommendation adds another market-access milestone for LEQEMBI as the therapy continues to expand globally. According to the companies, lecanemab has been approved in 53 countries and regions, including Japan, the United States, China, Europe, South Korea, Taiwan and Saudi Arabia, while additional regulatory reviews remain ongoing. The companies are also advancing different administration options, including intravenous and subcutaneous dosing approaches, with regulatory approvals and applications progressing across multiple markets. These developments reflect the broader effort to improve treatment accessibility and potentially simplify long-term administration for appropriate patients.
Canadian Reimbursement Process Moves Forward
The CDA-AMC recommendation now moves LEQEMBI closer to potential inclusion within Canada’s publicly funded healthcare system, but the remaining reimbursement process will determine how and where eligible patients can ultimately access treatment. Negotiations through the pCPA are expected to precede decisions by individual provincial and territorial drug plans, meaning access conditions may differ across jurisdictions. The recommendation therefore represents a significant regulatory and market-access development, but it should not be interpreted as a completed national reimbursement decision. For Eisai and Biogen, securing broader reimbursement remains an important component of the commercial development of lecanemab as the companies seek to expand access to eligible early Alzheimer’s disease patients. Eisai leads the global development and regulatory submissions for lecanemab, while Eisai and Biogen jointly commercialize and co-promote the product, with Eisai retaining final decision-making authority.
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Global LEQEMBI Development Continues
Beyond the Canadian reimbursement process, the LEQEMBI development program continues across earlier and genetically inherited forms of Alzheimer’s disease. The companies highlighted the ongoing AHEAD 3-45 Phase 3 study, which is evaluating lecanemab in individuals with preclinical Alzheimer’s disease who are clinically normal but have intermediate or elevated amyloid levels in the brain. The Tau NexGen clinical study is also investigating lecanemab as the backbone anti-amyloid therapy for dominantly inherited Alzheimer’s disease. The companies are additionally pursuing maintenance and subcutaneous administration strategies intended to expand treatment flexibility. For the Canadian market, the immediate focus now shifts toward pCPA negotiations and provincial and territorial reimbursement decisions, which will determine the practical availability of LEQEMBI for eligible patients. The positive CDA-AMC recommendation nevertheless marks a meaningful step in the continued expansion of disease-modifying Alzheimer’s treatment access.
Source: Eisai, Biogen, press relese
