The U.S. Food and Drug Administration (FDA) has accepted Eisai's Biologics License Application (BLA) and granted Priority Review for lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD. This action accelerates the potential approval timeline for a therapy targeting the underlying pathology of Alzheimer's. The Prescription Drug User Fee Act (PDUFA) action date is set for January 6, 2023.
Clinical Trial Data and Regulatory Pathway
The application's acceptance triggers a milestone payment of MEUR 15 from Eisai to BioArctic, the originator of lecanemab. The ongoing Clarity AD Phase 3 confirmatory clinical trial, which completed enrollment of 1,795 patients in March 2021, is expected to report primary endpoint data in the fall of 2022. The FDA has agreed that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab, supporting a potential traditional approval. Eisai intends to submit for traditional approval of lecanemab to the FDA before the end of the first quarter of 2023, contingent on the Clarity AD trial results.
Mechanism of Action and Target Population
Lecanemab is a humanized monoclonal antibody designed to selectively bind to, neutralize, and eliminate soluble toxic Aβ aggregates (protofibrils), which are believed to contribute to the neurodegenerative process in AD. By targeting these protofibrils, lecanemab aims to modify the disease's trajectory and slow its progression. The drug is intended for patients with early AD, characterized by mild cognitive impairment or mild dementia with confirmed amyloid pathology in the brain.
Prior Designations and Ongoing Studies
Lecanemab has received Breakthrough Therapy and Fast Track designations from the FDA, highlighting its potential to address an unmet medical need in a serious condition. Eisai has also initiated application data submission to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) for early approval. Furthermore, a Phase 3 clinical study, AHEAD 3-45, is ongoing for individuals with preclinical (asymptomatic) AD, conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium and Eisai. Lecanemab is also being investigated in a clinical trial for dominantly inherited Alzheimer's disease as a background anti-amyloid treatment.
Collaboration and Future Plans
BioArctic and Eisai have a long-term collaboration for developing and commercializing drugs for Alzheimer's disease. Eisai is responsible for the clinical development, market approval application, and commercialization of lecanemab. BioArctic is entitled to payments related to regulatory filings, approvals, sales milestones, and royalties on global sales. Eisai aims to file for manufacturing and marketing approval in the US, Japan, and the EU based on the results of the Clarity AD trial before the end of the first quarter of 2023.
