TOKYO and CAMBRIDGE, Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that Eisai has initiated submission of data for Biologics License Application (BLA) to the National Medical Products Administration (NMPA) of China for lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody.
The registration category of lecanemab was designated as a Category 1 drug (innovative biologics not approved in China or any other countries).
The data submitted in this package includes data from the Phase II clinical trial (Study 201) in mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed Aβ accumulation in the brain and the top-line data of the large global Phase III Clarity AD study. Eisai will submit additional data including full data of the Clarity AD study, as directed by the NMPA.
Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results. 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 New England Journal of Medicine, peer-reviewed medical journals.
In the U.S., lecanemab was granted Breakthrough Therapy and Fast Track designations by the U.S. Food and Drug Administration (FDA) in June and December 2021, respectively. In July 2022, the FDA accepted Eisai’s BLA for lecanemab under the accelerated approval pathway and granted it Priority Review. The Prescription Drug User Fee Act (PDUFA) action date is January 6, 2023. Eisai aims to file for traditional approval in the U.S. and for marketing authorization applications in Japan and the Europe by the end of Eisai’s FY2022, which ends March 31, 2023.
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.
Eisai Co., Ltd.
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Eisai Co., Ltd.
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