Eisai and Biogen are addressing additional queries from the European Commission (EC) regarding their Marketing Authorization Application for lecanemab, a treatment for early Alzheimer's disease (AD). The EC has requested the Committee for Medicinal Products for Human Use (CHMP) to re-evaluate lecanemab's safety data and risk minimization measures following a positive opinion issued in November 2024.
The CHMP is expected to discuss these requests during its meeting in February 2025. Eisai and Biogen are confident that the existing data adequately addresses the EC's concerns and will work closely with regulatory authorities to secure approval in the EU.
Lecanemab's Safety Profile
According to Eisai and Biogen, the safety profile of lecanemab observed in clinical practice in the United States, Japan, and other countries post-launch is consistent with the approved labels. No new safety signals have been identified, reinforcing the companies' confidence in the drug's risk-benefit profile.
Commitment to EU Patients
Both Eisai and Biogen have reiterated their commitment to making lecanemab available to patients with early AD in EU countries as soon as possible, emphasizing the significant unmet need for effective treatments in this patient population.
Lecanemab's Mechanism and Approvals
Lecanemab, marketed as Leqembi, is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody. It targets aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). It has already gained approval in the U.S., Japan, China, South Korea, Hong Kong, Israel, the United Arab Emirates, the United Kingdom, Mexico, and Macau. The U.S. FDA recently approved a supplemental Biologics License Application (sBLA) for less frequent, once-every-four-weeks maintenance dosing. Additionally, the FDA accepted a Biologics License Application (BLA) for a subcutaneous injection formulation for maintenance dosing, designed to improve patient convenience.
Ongoing Clinical Studies
Eisai's Phase 3 AHEAD 3-45 clinical study, evaluating lecanemab in individuals with preclinical AD (clinically normal with intermediate or elevated amyloid levels), is ongoing since July 2020. The Tau NexGen clinical study for Dominantly Inherited AD (DIAD), led by Washington University School of Medicine in St. Louis, has been ongoing since January 2022 and includes lecanemab as the backbone anti-amyloid therapy.
Collaboration
Eisai leads lecanemab's development and regulatory submissions globally, with Eisai and Biogen co-commercializing and co-promoting the product. Eisai retains final decision-making authority. Eisai and BioArctic have collaborated on AD treatments since 2005. Eisai obtained global rights to develop and market lecanemab under an agreement with BioArctic in December 2007.
