BIOLOGICS LICENSE APPLICATION FOR LECANEMAB DESIGNATED FOR PRIORITY REVIEW BY CHINA NATIONAL MEDICAL PRODUCTS ADMINISTRATION
TOKYO and CAMBRIDGE, Mass., February 28, 2023 – 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 the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China. The Priority Review and Approval Procedure was implemented by the NMPA with the aim of accelerating research, development and launch of new medicines that have significant clinical value. Under this Procedure, the assessment period is expected to be shortened.
In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022. Eisai initially submitted a package that includes data from the Phase II clinical trial (Study 201) and the top-line data of the large global Phase III Clarity AD study 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. 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, a peer-reviewed medical journal.
In the U.S., lecanemab was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023. On the same day, Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway. In Europe, Eisai submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023, which was accepted on January 26, 2023. In Japan, Eisai submitted a marketing authorization application to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023, and Priority Review was designated by the Ministry of Health, Labour and Welfare (MHLW) on January 26, 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.
| Contacts | |
| MEDIA CONTACT:
Eisai Co., Ltd. Public Relations Department TEL: +81-(0)3-3817-5120
INVESTOR CONTACT: Eisai Co., Ltd. Investor Relations Department TEL: +81-(0)3-3817-5122 |
MEDIA CONTACT:
Biogen Inc. Natacha Gassenbach + 1-857-777-6573 public.affairs@biogen.com
INVESTOR CONTACT: Biogen Inc. Mike Hencke + 1-781-464-2442 IR@biogen.com |