Eisai Maintains Commitment to People Living with Early Alzheimer's Disease Despite CDA-AMC Draft Recommendation: Patients Deserve Access to Effective Treatment Français
Decision overlooks compelling evidence that LEQEMBI ® (lecanemab-irmb) meaningfully slows the progression of Alzheimer's disease and preserves ability to perform activities of daily living for those in the early stages of disease
MISSISSAUGA, ON and TORONTO, Feb. 19, 2026 /CNW/ - Eisai Limited ("Eisai") and Biogen Canada Inc. are disappointed by and disagree with Canada's Drug Agency (CDA-AMC) that the Agency will not recommend LEQEMBI® for public reimbursement in Canada. This draft recommendation was made despite clinical data and evidence that treatment with LEQEMBI® slows both disease progression and functional decline in patients with early Alzheimer's Disease (AD).1,2
In October 2025, LEQEMBI® received a Notice of Compliance with conditions (NOC/c) from Health Canada, becoming the first treatment approved in Canada that targets an underlying cause of AD. The approval was based on the large global Phase 3 Clarity AD study, where the treatment consistently demonstrated statistical and clinically meaningful results across all endpoints relative to placebo treatment.1,2 LEQEMBI® is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment or mild dementia due to AD who are apolipoprotein E ε4 (ApoE ε4*) non-carriers or heterozygotes and who have confirmed amyloid pathology.
"We are deeply troubled by the CDA's draft recommendation, as it reached a fundamentally different conclusion on LEQEMBI®'s benefit-risk profile when compared to Health Canada's approval, and conflicts with the opinions of AD experts and patients on the value of this treatment. Health Canada clearly recognized LEQEMBI®'s ability to slow cognitive and functional decline in early Alzheimer's disease," said Patrick Forsythe, Vice President & General Manager, Eisai Limited. "Eisai stands behind the clinical effectiveness of LEQEMBI® for the approved indication. We remain committed to a patient-centered approach and ensuring this treatment is available for eligible people living with early AD in Canada."
"People living with early Alzheimer's disease and their care partners have consistently told us that slowing disease progression and preserving autonomy matter deeply," said Christina Scicluna, CEO, Alzheimer's Society of Canada. "While evidence-based review processes are essential given the limited treatment options available, this decision reinforces the need for more equitable access to treatments for those who need it most."
"I have had the privilege of following my patients on LEQEMBI® in clinical trials, and I have personally witnessed the joy of those who have remained at an early stage for an extended period of time," shares Dr. Sharon Cohen, Neurologist, Medical Director, Toronto Memory Program. "LEQEMBI® represents an important change in how we approach Alzheimer's disease, and its value must be clearly recognized with the same urgency and commitment as we do for treatments of other serious diseases. Denying access to LEQEMBI® will eliminate an important opportunity for Canadians to reap the benefits of a treatment shown to slow disease. Those dealing with early AD are deserving of the profound hope that comes with access to this treatment."
Recent four-year data presented at the 2025 Alzheimer's Association International Conference (AAIC) suggested that continued treatment with LEQEMBI® can help slow disease progression for 10 to 13 months while patients remain in the early stages of AD.3,4
Eisai remains deeply committed to a patient-centered approach in Alzheimer's care and ensuring LEQEMBI® is available to those eligible and living with early AD in Canada. We will continue to pursue all possible options for public reimbursement in Canada and continue to advocate for equitable access to care.
The draft recommendation for LEQEMBI® is currently open and accepting stakeholder feedback until March 5, 2026. Feedback can be submitted by visiting cda-amc.ca/lecanemab.
*Apolipoprotein E is a protein involved in the metabolism of lipid in humans. It is implicated in AD. People with only one (heterozygous) or no copy (non-carriers) of the ApoE ε4 gene are less likely to experience Amyloid Related Imaging Abnormalities (ARIA) than people with two ApoE ε4 copies (homozygous).5
Notes to Editors
- 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 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms (plaques) of amyloid-beta (Aβ). Protofibrils are believed to contribute to the brain injury that occurs with AD and are considered to be the most toxic form of Aβ, having a primary role in the cognitive decline associated with this progressive, debilitating condition.1 Protofibrils cause injury to neurons in the brain, which in turn, can negatively impact cognitive function via multiple mechanisms, not only increasing the development of insoluble Aβ plaques but also increasing direct damage to brain cell membranes and the connections that transmit signals between nerve cells or nerve cells and other cells. It is believed the reduction of protofibrils may prevent the progression of AD by reducing damage to neurons in the brain and cognitive dysfunction.6
Lecanemab has been approved in 53 countries and regions including Japan, the United States, Europe, China, 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 was approved in 7 countries including the U.S., China, the United Kingdom, and applications have been filed in 7 countries and regions. The U.S. FDA approved Eisai's Biologics License Application (BLA) for subcutaneous maintenance dosing with LEQEMBI IQLIK in August 2025. In September 2025, the rolling sBLA application to the U.S. FDA for the subcutaneous initiation dosing with LEQEMBI IQLIK was initiated and accepted in January 2026 with an anticipated Prescription Drug User Fee Act (PDUFA) date of May 24, 2026.
Since July 2020, the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in AD and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited AD (DIAD), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy. - 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. - 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. - 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. - 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). - 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 not 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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Media Contacts:
Eisai Limited (Canada)
Kristina Gentes
+1-365-383-3342
[email protected]
Eisai Inc. (U.S.)
Libby Holman
+1-201-753-1945
[email protected]
Biogen Canada Inc.
Marija Mandic
+1-416-234-7901
[email protected]
References
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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 Early Alzheimer's Patients Continue to Benefit from Four Years of LEQEMBI® (lecanemab-irmb) Therapy New Clinical Data Presented at AAIC. News release. Biogen. Available at: https://investors.biogen.com/news-releases/news-release-details/early-alzheimers-patients-continue-benefit-four-years-leqembir |
4 van Dyck CH. Open-Label Extension Results of Lecanemab in Early Alzheimer's Disease. Presented at: Alzheimer's Association International Conference (AAIC); July 2025; Philadelphia, PA. Available at: https://static1.squarespace.com/static/5cdeb7d2d1fedc00011c178e/t/68880e562ec2e442f188d4e7/1753747031384/van+Dyck+OLE+-+2025+AAIC+-+FINAL.pdf |
5 Amin L, Harris DA. Aβ receptors specifically recognize molecular features displayed by fibril ends and neurotoxic oligomers. Nat Commun. 2021;12(1):3451. Published 2021 Jun 8. doi:10.1038/s41467-021-23507-z |
6 Ono K, Tsuji M. Protofibrils of Amyloid-β are Important Targets of a Disease-Modifying Approach for Alzheimer's Disease. Int J Mol Sci. 2020;21(3):952. Published 2020 Jan 31. doi:10.3390/ijms21030952 |
SOURCE Eisai Limited
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