BioArctic's Subcutaneous Leqembi® Receives Approval in China
BioArctic AB's (publ) partnership with Eisai has achieved a significant milestone with the acceptance of the Biologics License Application (BLA) for the subcutaneous formulation of Leqembi (lecanemab), aimed at treating early Alzheimer's disease. This acceptance by the National Medical Products Administration (NMPA) in China highlights the potential for this innovative treatment to be the first anti-amyloid therapy available for home administration, changing the landscape for Alzheimer's treatment.
Should this application receive final approval, patients will be able to self-administer a once-weekly dose of lecanemab at home, using a convenient subcutaneous autoinjector. This is in stark contrast to the traditional intravenous (IV) administration required every two weeks in a hospital setting, which can be cumbersome and limit accessibility for many patients. The autoinjector is designed for ease of use, delivering a 250 mg dose in around 15 seconds.
This new method of administration not only enhances convenience for patients and caregivers but also promises to lessen the demands on healthcare systems by reducing the resources previously needed for IV treatments, such as nurse administration and handling of sterile infusion preparations. Streamlining treatment in this way could revolutionize the care pathway for individuals living with Alzheimer's disease.
Growing Demand for Alzheimer's Treatments
In China, the prevalence of Alzheimer’s-related conditions is striking, with approximately 17 million individuals suffering from mild cognitive impairment or early dementia, a figure projected to rise with the aging demographic. Eisai anticipates that demand for accessible treatment options will only increase as the population continues to grow older.
In addition to this exciting news from China, similar applications for lecanemab's subcutaneous administration have been filed with the U.S. Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency. Lecanemab is already approved in the U.S. for maintenance dosing via subcutaneous injection under the trade name Leqembi Iqlik™.
The Journey of Leqembi: Collaboration and Innovation
The development of Leqembi is the result of a fruitful collaboration between BioArctic and Eisai, rooted in extensive research, including the pioneering work of Professor Lars Lannfelt, who uncovered the Arctic mutation related to Alzheimer's disease. Under this partnership, Eisai navigates the clinical development processes, handles regulatory approvals, and oversees commercialization efforts for Leqembi globally. BioArctic, while sharing the commercial right to Leqembi in the Nordic area, focuses on innovative strategies to bring this groundbreaking therapy to market.
Lecanemab is already making waves internationally, with approvals already secured in over 52 countries and ongoing regulatory reviews in eight others. It is important to note that, following an initial 18-month phase of bi-weekly intravenous treatment, lecanemab is recognized for its maintenance dosing every four weeks in locations such as the United Kingdom, the U.S., and beyond.
Clinical Trials and Future Studies
Ongoing clinical studies further underscore the commitment of BioArctic and Eisai to advancing Alzheimer’s treatment. AHEAD 3-45, a Phase 3 clinical study, has been investigating lecanemab's efficacy in preclinical Alzheimer’s patients since its initiation in July 2020. Recruitment for this extensive four-year study was completed by October 2024 and continues to gather vital data for future therapeutic applications.
Another notable study, conducted by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), aims to evaluate lecanemab's efficacy in patients with Dominantly Inherited Alzheimer's Disease, adding to the growing body of evidence supporting lecanemab as a fundamental component of Alzheimer's treatment.
About BioArctic AB
Founded in 2005, BioArctic AB is a Swedish biopharma company dedicated to discovering and developing cutting-edge treatments for neurodegenerative diseases. At the forefront of its research is Leqembi® (lecanemab), the first drug proven to slow cognitive decline in early Alzheimer's disease, developed alongside Eisai. The company is also actively exploring therapies for conditions such as Parkinson's disease and ALS, leveraging its proprietary BrainTransporter™ technology to enhance treatment delivery across the blood-brain barrier.
BioArctic's B shares (BIOA B) are traded on the Nasdaq Stockholm Large Cap, reflecting the company’s commitment to innovation and improvement in the treatment landscape for neurodegenerative diseases.
Frequently Asked Questions
What is Leqembi?
Leqembi is a monoclonal antibody designed to treat early Alzheimer's disease by targeting amyloid-beta in the brain.
What new formulation is BioArctic launching?
BioArctic is introducing a subcutaneous formulation of Leqembi, allowing for home administration via an autoinjector.
Why is the acceptance of the BLA significant?
The acceptance signifies potential new treatment options for patients with Alzheimer's and emphasizes ease of administration.
What is the partnership between BioArctic and Eisai?
The partnership encompasses the development, regulatory approval, and commercialization of Alzheimer’s therapies, with both companies contributing expert resources.
Where is Leqembi approved?
Leqembi is approved in 52 countries and is under review in several others, showcasing its growing international acceptance.
