Canada's Drug Agency Issues Final Positive Recommendation Supporting Public Reimbursement of LEQEMBI(R) (lecanemab) for Early Alzheimer's Disease

TOKYO and CAMBRIDGE, Mass., September 8, 2026 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced today that Canada’s Drug Agency (CDA-AMC) has issued a final recommendation supporting public reimbursement of LEQEMBI® (lecanemab) for eligible patients in Canada living with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease (early AD).

The final recommendation follows a reconsideration by CDA-AMC and is an important step toward access to LEQEMBI. Next steps include negotiations through the pan-Canadian Pharmaceutical Alliance (pCPA), followed by individual reimbursement decisions by public drug plans in Canada’s provinces and territories.

More than 770,000 people in Canada were estimated to be living with dementia in 2025, and the number of people living with dementia in Canada is projected to increase to 1.7 million by 2050.¹

Eisai serves as the lead for lecanemab’s development and regulatory submissions globally, with Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.

MEDIA CONTACTS

Eisai

Eisai Co., Ltd.
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Eisai Europe, Ltd.
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Emea-comms@eisai.net

Eisai Inc. (U.S.)
Libby Holman
+1-201-753-1945
Libby_Holman@Eisai.com 

Biogen Inc.

Madeleine Shin
+1-781-464-3260
public.affairs@biogen.com

INVESTOR CONTACTS

Eisai Co., Ltd.
Investor Relations Department
TEL: +81 (0)3-3817-5122

Biogen Inc.
Tim Power
+ 1-781-464-2442
IR@biogen.com

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 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 8 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.

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 Protofibrils

Protofibrils are thought to be the most toxic Aβ species that contribute to brain damage in AD and play a major role in the cognitive decline of this progressive and devastating disease. Protofibrils can cause neuronal and synaptic damage in the brain, which can subsequently adversely affect cognitive function through multiple mechanisms.2 The mechanism by which this occurs has been reported not only by increasing the formation of insoluble Aβ plaques, but also by directly damaging signaling between neurons and other cells. It is believed that reducing protofibrils may reduce neuronal damage and cognitive impairment, potentially preventing the progression of AD.3

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 both companies 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 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.), and connect with us on X, LinkedIn and Facebook. The website and social media channels are intended for audiences outside of the UK and Europe. For audiences based in the UK and Europe, please visit www.eisai.eu and Eisai EMEA LinkedIn.

About Biogen

Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patient’s 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.

The company routinely posts information that may be important to investors on its website at www.biogen.com. Follow Biogen on social media – Facebook, LinkedIn, X, YouTube.