Lecanemab Approved for Alzheimer's Treatment in Multiple Countries

Lecanemab, a monoclonal antibody targeting amyloid-beta (Aβ) in its aggregated soluble (protofibril) and insoluble forms, has received approval in the United States, Japan, China, South Korea, Hong Kong, Israel, UAE, and Great Britain. It is approved for treating mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) and mild AD dementia. These approvals are based on successful Phase 3 trials, particularly the Clarity AD clinical trial conducted by Eisai, which achieved its primary and secondary endpoints with statistical significance. Common adverse reactions include infusion reactions, ARIA-H, ARIA-E, headache, and falls.

Lecanemab is marketed in the U.S., Japan, and China, with Eisai having submitted approval applications in 10 additional regions, including the European Union. Since July 2020, Eisai has been conducting the AHEAD 3-45 clinical study for individuals with preclinical AD, in collaboration with the Alzheimer's Clinical Trial Consortium and funded by the National Institute on Aging. Additionally, since January 2022, the Tau NexGen study for Dominantly Inherited Alzheimer's Disease (DIAD) is underway, led by Washington University School of Medicine, incorporating lecanemab as a primary therapy.

BioArctic and Eisai have collaborated since 2005 on Alzheimer's disease treatments. Their key agreements include the 2007 Development and Commercialization Agreement for lecanemab and the 2015 agreement for a backup antibody, Leqembi. Eisai manages clinical development and global commercialization, while BioArctic retains commercialization rights in the Nordic region. BioArctic incurs no development costs for lecanemab but benefits from milestone payments and royalties.

BioArctic AB, a Swedish biopharma company, focuses on innovative treatments for neurodegenerative diseases. It developed Leqembi® (lecanemab), the first drug to slow Alzheimer's disease progression and reduce cognitive decline. BioArctic's portfolio also includes research on Parkinson's disease and ALS, utilizing its BrainTransporter™ technology to enhance treatment efficacy. BioArctic's B share is listed on Nasdaq Stockholm Large Cap.