European Medicines Agency Accepts Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer’s Disease

Lecanemab, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody, targets aggregated soluble and insoluble forms of amyloid-beta (Aβ), specifically binding and eliminating Aβ protofibrils believed to contribute to Alzheimer’s disease neurotoxicity. This mechanism suggests lecanemab could impact disease pathology and potentially slow disease progression.

In the United States, lecanemab was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023, for treating Alzheimer’s disease, specifically in patients with mild cognitive impairment or mild dementia. The approval is based on observed reductions in Aβ plaques in treated patients, with continued approval contingent upon further verification of clinical benefits in confirmatory trials.

Eisai, leading the global development and regulatory submissions for lecanemab, has submitted marketing authorization applications in Japan and is in the process of submitting a Biologics License Application (BLA) in China. BioArctic holds the rights to commercialize lecanemab in the Nordic region under certain conditions and is preparing for commercialization alongside Eisai.

The Clarity AD study, a Phase III confirmatory trial for lecanemab, met its primary endpoint and all key secondary endpoints with highly statistically significant results. Additionally, Eisai is evaluating subcutaneous dosing in the Clarity AD open-label extension study and conducting the AHEAD 3-45 study for individuals with preclinical Alzheimer’s disease. The Tau NexGen clinical study for Dominantly Inherited Alzheimer’s Disease (DIAD) is also ongoing, exploring combination therapies with anti-tau treatments.

BioArctic and Eisai have collaborated since 2005 on the development and commercialization of Alzheimer’s disease treatments, with significant agreements focusing on lecanemab and its backup, BAN2401. Eisai, in partnership with Biogen, is responsible for the clinical development, market approval applications, and commercialization of Alzheimer’s disease treatments, while BioArctic benefits from payments related to regulatory filings, approvals, sales milestones, and royalties on global sales without bearing development costs.