Lecanemab

July 14, 2026 -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a once weekly lecanemab irmb subcutaneous injection (US brand name: Leqembi Iqlik®) as a starting dose for the treatment of early Alzheimer's disease. The US launch is planned for late August 2026. Leqembi Iqlik is a first-of-its-kind anti-amyloid treatment worldwide, offering at-home dosing for initiation and maintenance. It is administered via an autoinjector, offering a convenient alternative to intravenous (IV) infusion from the start of treatment. For initiation, the approved regimen is 500 mg once weekly, delivered as two 250 mg injections, each administered in approximately 15 seconds. Leqembi Iqlik is already approved for maintenance dosing in the US at 360 mg once weekly, once 18 months of IV or subcutaneous treatment has been completed. Patients can now receive Leqembi either as an IV infusion or as a subcutaneous injection (SC) with Leqembi Iqlik throughout the entire treatment course - from initiation through maintenance and may switch between administration methods as needed, providing greater flexibility and convenience. Leqembi is indicated in the US for the treatment of adults with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease, collectively referred to as early Alzheimer's disease. MCI due to Alzheimer's disease represents the earliest symptomatic stage of the disease and may be associated with subtle changes in memory, thinking, language, or daily functioning. The FDA approval of Leqembi Iqlik for treatment initiation is supported by a comprehensive clinical data package evaluating SC administration of lecanemab across multiple studies and dosing regimens. Data from sub-studies within the Phase 3 Clarity AD long-term extension (LTE), conducted following the 18-month core study in individuals with early Alzheimer's disease, showed: Once-weekly subcutaneous administration achieved exposure equivalent to intravenous dosing, supporting similar clinical (efficacy) and biomarker (amyloid removal) benefits. The rate of exposure-related adverse events such as ARIA-E with SC administration is expected to be comparable with IV administration. There was no increase in isolated ARIA-H (i.e., ARIA-H in patients who did not also experience ARIA-E) for Leqembi compared to placebo. The overall safety profile of SC administration was generally similar to intravenous administration. Injection-related reactions were observed with subcutaneous Leqembi, most of which were localized, while systemic reactions were less frequently observed. "This approval represents another important step forward in the treatment of Alzheimer's disease," said Gunilla Osswald, CEO of BioArctic. "By providing a new administration option from the start of treatment, patients, caregivers and healthcare professionals gain greater flexibility in how therapy is delivered. As the Alzheimer's treatment landscape continues to advance, innovations that simplify access and support individualized care will be increasingly important. We are encouraged to see Eisai's diligent work to meet the diverse needs of people living with this difficult disease." The approval of Leqembi Iqlik as a subcutaneous starting dose provides patients and care partners with the only at-home administration option throughout the Alzheimer's disease treatment journey which could support access and delivery of care across healthcare settings. Subcutaneous administration may: Reduce the burden of clinic visits for patients and care partners Reduce reliance on infusion and associated healthcare resources Decrease treatment preparation and administration time, and nursing monitoring requirements Preserve infusion capacity for patients who prefer or require intravenous therapy Insights from an autoinjector acceptability study indicated that 94% of patients with early Alzheimer's disease and their care partners found the Leqembi Iqlik device easy to use, with high levels of satisfaction and confidence in using it in an at-home setting[1] Leqembi is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Leqembi is approved in 53 countries 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 United Kingdom, China, the US and Japan, and applications have been filed in 12 countries and regions. In the US, Leqembi Iqlik ® is approved for subcutaneous dosing with an autoinjector as a starting dose and maintenance treatment of early Alzheimer's disease. In November 2025, a new drug application for subcutaneous formulation of Leqembi was submitted in Japan. In December 2025, Leqembi was included in the "Commercial Insurance Innovative Drug List", recently introduced by the National Healthcare Security Administration (NHSA) of China. In January 2026, the Biologics License Application for subcutaneous formulation of Leqembi was accepted in China and in February, the application was designated for priority review. Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's disease and related dementias in the US, funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (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. Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody lecanemab back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with sales milestones as well as royalties on global sales. BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. [1]Based on in-person interviews of 50 patients with early Alzheimer's Disease and 50 care partners currently assisting people with early AD. Participants were given the opportunity to interact with a training autoinjector device (containing no needles or medication) and an injection pad, then asked to answer computer-based surveys about their experience, including "How difficult or easy was it to use the self-injection device?" The content above comes from the network. if any infringement, please contact us to modify.

Canada's Drug Agency recognizes the clinical value of LEQEMBI ® in slowing Alzheimer's progression and helping keep patients in earlier stages of disease for longer MISSISSAUGA, ON and TORONTO , July 16, 2026 /CNW/ -- Eisai Limited ("Eisai") and Biogen Canada Inc. are honoured to be one of the first countries in the world to receive a positive Health Technology Assessment recommendation for public reimbursement, as announced today by Canada's Drug Agency (CDA-AMC). This decision demonstrates that CDA-AMC recognizes the significant unmet need for a disease modifying treatment for early Alzheimer's disease (AD). It is clear that CDA-AMC listened to the extensive and consistent feedback from clinical experts, patients and stakeholders as well as the review of new 48-month data which demonstrates the benefits of continuous treatment with LEQEMBI. This represents a historic milestone, supports equitable access for patients, and brings eligible Canadians one step closer to accessing the first treatment approved in Canada that targets the underlying biology of Alzheimer's disease (AD) and may help keep patients in the earlier stages of disease for longer. 1 , 2 The positive recommendation overturns the CDA-AMC's previous draft recommendation, incorporating the evidence and stating that "lecanemab is likely to provide meaningful benefit in addressing some unmet needs in early Alzheimer's disease such as delaying progression". 3 One of the key takeaways from the CDA-AMC review of the 48-month data analysis was that it suggests "increasing treatment effect compared with earlier time points (18 and 36 months)", 3 meaning that the treatment benefits of LEQEMBI increase over time. People living in the earliest stage of AD, also known as mild cognitive impairment (MCI) is the phase prior to dementia, when individuals are usually still functioning independently and playing an active role in daily life, such as caring for grandchildren, volunteering or even acting as caregiver to their own partners. 4 ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); "We welcome CDA-AMC's recommendation, which underscores the significant value LEQEMBI brings to patients and highlights the urgent need for treatments that, for the first time, modify the course of early AD," said Pat Forsythe, Vice President & General Manager, Eisai Limited. "This recommendation reflects a shared commitment to improving Alzheimer's care and offers new hope to patients and families across most of the country. It also reflects the strong support of Canadians, whose voices continue to highlight the importance of expanding equitable access to new treatment options for those living with this disease." AD is the most common form of dementia, accounting for 60 to 80% of all cases. 5 In Canada, more than 771,000 people are living with dementia -- a number projected to rise to approximately 1 million by 2030. 6 "We are heartened by CDA-AMC's recommendation to reimburse lecanemab on public drug plans, which reflects input from Alzheimer Societies and partners across the country and marks a significant milestone for Canadians affected by Alzheimer's disease," said Christina Scicluna, CEO, Alzheimer Society of Canada. "This is a time of hope in the Alzheimer's community, with scientific advances creating new opportunities to slow decline and help people maintain their independence for longer. Today's decision is an important step forward and reinforces the urgent need for equitable access to a system that supports Canadians throughout their Alzheimer's journey, which includes sustained investments in navigation, diagnosis, treatment, and community supports." "What a huge relief that CDA-AMC has listened and understood the value of preserving function and quality of life at early stages of AD, such that individuals can remain active and engaged in activities that matter to them and to their families," said Dr. Sharon Cohen, Neurologist and Medical Director of Toronto Memory Program. "We are now one step closer to more equitable access to a treatment that slows AD. Canadians will appreciate this milestone." "As we strive to deliver equitable care in Canada, this decision represents a meaningful step forward for Canadians living with AD and for the health system," said Dr. Jo-Anne Clarke, Medical Director of the North-East Specialized Geriatric Centre. "Many individuals in the early stages of AD remain highly functional, continue to work and contribute meaningfully to their communities, and in many cases support their own families in caregiving. Equitable public access in northern and rural communities across Canada, to treatments like LEQEMBI, offers meaningful and much-needed hope to patients for extending this period of independence, and the opportunity to create more consistent care pathways, ensuring more Canadians can benefit from timely diagnosis and treatment." The draft recommendation for LEQEMBI is currently open and accepting stakeholder feedback until July 30, 2026. Feedback can be submitted by visiting cda-amc.ca/lecanemab . Eisai remains deeply committed to a patient-centered approach in Alzheimer's care and is dedicated to working closely with healthcare systems and stakeholders to ensure that eligible individuals living with early AD can access LEQEMBI as quickly as possible. Eisai will continue to collaborate with provinces and territories to support effective and timely implementation of public coverage across Canada. 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 (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 United States, 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 was 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. A Supplemental Biologics License Application (sBLA) for initiation treatment was accepted in January 2026 and granted Priority Review. The sBLA has been assigned an extended Prescription Drug User Fee Act (PDUFA) action date of August 24, 2026. In November 2025, an application for a subcutaneous injectable formulation in Japan was submitted. In January 2026, the Biologics License Application (BLA) for the subcutaneous formulation was accepted in China. In 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 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 (for global headquarters: Eisai. Co., Ltd.), us.eisai.com (for U.S. headquarters: Eisai Inc.) or (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 . 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. 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N Engl J Med. 2023;388(1):9-21. doi:10.1056/NEJMoa2212948 3 Canada's Drug Agency (CDA-AMC). Leqembi draft recommendation. Available at: 4 Alzheimer Society of Canada. Mild cognitive impairement. Available at: 5 Alzheimer Society of Canada. What is Alzheimer's disease? Available at: . 6 Alzheimer Society of Canada. Dementia numbers in Canada. Available at: . Media Contacts: Eisai Limited (Canada) Ashley Concessio +1-437-451-4519 Ashley_Concessio@eisai.com Eisai Inc. (U.S.) Libby Holman +1-201-753-1945 Libby_Holman@eisai.com Biogen Canada Inc. Karla Fuentes Arellano +1-416-717-5152 can-communicationscanada@biogen.com SOURCE Eisai Limited