Final CDA-AMC Recommendation Brings Canadians with Early-Stage Alzheimer's Disease One Step Closer to Accessing LEQEMBI® (lecanemab)
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Recommendation advances equitable access discussions for eligible Canadians and highlights the urgency of timely reimbursement, as Alzheimer's disease progression does not wait
MISSISSAUGA, ON and TORONTO, Aug. 27, 2026 /CNW/ -- Eisai Limited ("Eisai") and Biogen Canada Inc. are pleased to receive Canada's Drug Agency (CDA-AMC)'s final positive recommendation supporting public reimbursement for LEQEMBI® (lecanemab), for eligible Canadians living with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease (early AD).
This recommendation marks an important step forward toward equitable access for Canadians affected by AD and follows CDA-AMC's comprehensive review of clinical data, including new 48-month data demonstrating the benefits of continuous treatment with LEQEMBI, as well as extensive input from clinical experts, patients and stakeholders.
The completion of CDA-AMC's review is a positive recognition of the value of LEQEMBI and paves the way for reimbursement discussions. Canadians have already waited a long time for treatment options. AD is a progressive disease and additional delays create a risk for eligible patients today who will progress beyond the stage where treatment is indicated.
"CDA-AMC's final recommendation brings eligible Canadians living with early AD even closer to equitable access to LEQEMBI, marking a pivotal moment for patients and families who have been waiting years for this," said Pat Forsythe, Vice President & General Manager, Eisai Limited. "We now have the opportunity to put this recommendation into action, and encourage those involved in the reimbursement process to move forward as efficiently as possible."
LEQEMBI is the first treatment approved in Canada that targets the underlying biology of AD and may help keep patients in the earlier stages of disease for longer.1,2 For people living with early AD, preserving time in the early stages of disease can be especially meaningful, as many individuals are still functioning independently and actively contributing to their families and communities.3
"For individuals living with early Alzheimer's disease and their care partners, every opportunity to preserve time, independence and meaningful moments is important. That's why treatments that can slow progression of the disease are significant," said Christina Scicluna, CEO, Alzheimer Society of Canada. "We welcome this recommendation, as it represents a step forward in expanding access to treatment options and gives more hope to Canadians who are affected by Alzheimer's disease."
"This recommendation reinforces the imperative of making approved treatments accessible to eligible Canadians at early stages of Alzheimer's disease when treatments can have a meaningful benefit," said Dr. Sharon Cohen, Neurologist and Medical Director of Toronto Memory Program. "Alzheimer's is a progressive disease. Early initiation of treatment preserves independence and quality of life. Delays in treatment lead to lost opportunities for patients and their families which cannot be reversed. CDA's positive recommendation is a significant step forward and we must now work towards equitable implementation of timely cost coverage across our country to ensure that individuals do not progress beyond the treatment window."
Eisai remains deeply committed to a patient-centered approach in AD care. We are dedicated to working closely with governments, healthcare providers and community partners to support the implementation of AD care pathways and help eligible Canadians access LEQEMBI following reimbursement decisions by public drug plans.
Notes to Editors
1. About lecanemab (generic name, brand name: LEQEMBI)
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).
Lecanemab has been approved in 53 countries and regions including Canada, Japan, the U.S., China, Europe, South Korea, Taiwan, and Saudi Arabia, and is under regulatory review in 6 countries. Following the initial phase with treatment every two weeks for 18 months, intravenous (IV) maintenance dosing with treatment every four weeks is approved in 9 countries including the U.S., China, the UK, and others, and applications have been filed in 12 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. For subcutaneous initiation treatment (500 mg), approval was obtained in the United States in July 2026, and applications are under review in four countries, including Japan and China. In China, the application has been granted Priority Review designation. Since December 2025, lecanemab (IV) has been included in the "Commercial Insurance Innovative Drug List," recently introduced by the National Healthcare Security Administration (NHSA) of China.
LEQEMBI's approvals in these countries were based on Phase 3 data from Eisai's global placebo-controlled, double-blind, parallel-group, randomized Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. The primary endpoint was the global cognitive and functional scale, Clinical Dementia Rating Sum of Boxes (CDR-SB). Clarity AD evaluated lecanemab 10 mg/kg bi-weekly IV treatment of early Alzheimer's disease, which involved 1,795 patients (treatment group: 898, placebo group: 897). 95% of patients who completed the core study (18 months) chose to continue in the long-term extension study (LTE), with 478 patients still receiving treatment for four years. In the Clarity AD core clinical study, data showed LEQEMBI IV significantly slowed disease progression at 18 months (27% vs placebo), and the mean change from baseline between the lecanemab treated group and the placebo group after 18 months was -0.45 (P=0.00005) on the primary endpoint of CDR-SB global cognitive and functional scale.
2. About the Collaboration between Eisai and Biogen for AD
Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of lecanemab development and regulatory submissions globally with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
3. About the Collaboration between Eisai and BioArctic for AD
Since 2005, Eisai and BioArctic have had a long-term collaboration regarding the development and commercialization of AD treatments. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement with BioArctic in December 2007. The development and commercialization agreement on the antibody lecanemab back-up was signed in May 2015.
4. About Eisai Canada
Eisai Canada was established in 2011, one of more than 40 subsidiaries of global, industry-leader Eisai Co., Ltd. Rooted in Eisai's focus on delivering human health care (hhc), Eisai Canada is on a mission to support all Canadians by creating solutions in areas where significant medical challenges and treatment gaps persist. Eisai Canada's commitment to innovative R&D and open collaboration across lines of business, industry, language and culture has resulted in an industry-leading pipeline in Neurology and Oncology. Powered by the strength of our collaborations, we discover and deliver medicines that matter to people living with Cancer, Epilepsy, Insomnia and Alzheimer's Disease.
5. About Eisai Co., Ltd.
Eisai's Corporate Concept is "to give first thought to patients and people in the daily living domain, and to increase the benefits that health care provides." Under this Concept (also known as human health care (hhc) Concept), we aim to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to create and deliver innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.
In addition, we demonstrate our commitment to the elimination of neglected tropical diseases (NTDs), which is a target (3.3) of the United Nations Sustainable Development Goals (SDGs), by working on various activities together with global partners.
For more information about Eisai, please visit www.eisai.com (for global headquarters: Eisai. Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai Inc.) or www.eisai.eu (for Europe, Middle East, Africa, Russia, Australia and New Zealand headquarters: Eisai Europe Ltd.), and connect with us on X (global and U.S.), LinkedIn (for global, U.S. and EMEA) and Facebook (global).
6. About Biogen and Biogen Canada Inc.
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth.
Biogen has been proudly serving Canadian patients for more than 25 years. For information about Biogen Canada, please visit www.biogen.ca.
Biogen Safe Harbor
This news release contains forward-looking statements, including about the potential clinical effects of lecanemab (LEQEMBI); the potential benefits, safety and efficacy of LEQEMBI; potential regulatory discussions, submissions and approvals and the timing thereof, including Canada's Drug Agency's decision to recommend LEQEMBI for public reimbursement in Canada; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as "aim," "anticipate," "assume," "believe," "contemplate," "continue," "could," "estimate," "expect," "forecast," "goal," "guidance," "hope," "intend," "may," "objective," "outlook," "plan," "possible," "potential," "predict," "project," "prospect," "should," "target," "will," "would" or the negative of these words or other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements.
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2 van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023;388(1):9-21. doi:10.1056/NEJMoa2212948 |
3 Alzheimer Society of Canada. Mild cognitive impairment. Available at: https://alzheimer.ca/en/about-dementia/other-types-dementia/conditions-related-dementia/mild-cognitive-impairment |
Media Contacts:
Eisai Limited (Canada)
Ashley Concessio
+1-437-451-4519
[email protected]
Eisai Inc. (U.S.)
Libby Holman
+1-201-753-1945
[email protected]
Biogen Canada Inc.
Karla Fuentes Arellano
+1-416-717-5152
[email protected]
SOURCE Eisai Limited
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