Eisai Submits Marketing Application for lecanemab for Alzheimer’s

BioArctic AB’s partner Eisai announced today that Eisai has submitted a marketing authorization application for lecanemab, 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 dementia (collectively known as early AD) with confirmed presence of amyloid pathology in the brain to the Pharmaceuticals and Medical Devices Agency (PMDA). In conjunction with the regulatory filing in Japan announced today, and the subsequent acceptance of the file by PMDA, BioArctic is entitled to a milestone of MEUR 5.

This application is based on the results of the Phase 3 Clarity AD study and Phase 2b clinical study, which demonstrated that lecanemab-treatment reduced clinical decline in early AD. Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab.

In the Clarity AD study, lecanemab treatment resulted in highly statistically significant results, reducing clinical decline on the global cognitive and functional scale as the primary endpoint (CDR-SB[2]: Clinical Dementia Rating-Sum of Boxes) as early as six months, and over time across all time points. All key secondary endpoints also showed highly statistically significant results. Especially, treatment with lecanemab showed a statistically significant reduction in amyloid plaque burden at all timepoints starting at three months in the amyloid PET study and statistically significantly slowed decline of activities of daily living on ADCS MCI-ADL[3]. The most common adverse events (>10%) in the lecanemab group were infusion reactions, ARIA-H (combined cerebral microhemorrhages, cerebral macrohemorrhages, and superficial siderosis), ARIA-E (edema/effusion), headache, and fall.

In November 2022, the results of the Clarity AD study were presented at the 2022 Clinical Trials on Alzheimer’s Disease (CTAD) conference, and simultaneously published in the peer-reviewed medical journal New England Journal of Medicine.

In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the Food and Drug Administration (FDA) on January 6, 2023. Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for full approval under the traditional pathway on the same day. In Europe, Eisai submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023. In China, Eisai initiated submission of data for a BLA to the National Medical Products Administration (NMPA) in December 2022.

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has right to commercialize lecanemab in the Nordic under certain conditions and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer’s disease and is entitled to payments in connection with regulatory filings, approvals, and sales milestones as well as royalties on global sales.