Confirmatory Phase 3 Clarity AD data to be evaluated by FDA in determining whether to convert accelerated approval of LEQEMBI to a traditional approval
Priority Review accelerates FDA review time with a Prescription Drug User Fee Act (PDUFA) target action on July 6, 2023
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.
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 an application for manufacturing and marketing approval for lecanemab (generic name, U.S. brand name: LEQEMBI?), an anti-amyloid-β (Aβ) protofibril* antibody, in Japan has been designated for Priority Review by the Japanese Ministry of Health, Labour and Welfare (MHLW).
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has been listed in the 2023 Global 100 Most Sustainable Corporations in the World (Global 100), a global ranking by Canada-based media and investment advisory company, Corporate Knights, Inc. This marks Eisai’s seventh inclusion on the list. Ranked 53rd, Eisai was the highest ranking company among global pharmaceutical companies (please visit here for the Global 100 ranking).
Accelerated Approval is based on Phase 2 data showing a reduction in amyloid-beta plaques in early AD patients treated with LEQEMBI?
Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials
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.
TOKYO and Osaka, December 22, 2022? – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, “Astellas”), Eisai Co., Ltd. (TSE: 4523, CEO: Haruo Naito, “Eisai”), Daiichi Sankyo Company, Limited (TSE: 4568, President : Sunao Manabe, “Daiichi Sankyo”) and Takeda Pharmaceutical Company Limited. (TSE: 4502 / NYSE:TAK, President and CEO Christophe Weber, “Takeda”) today announced that the four companies have agreed the collaboration to reduce environmental burden in the field of pharmaceutical packaging.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has entered into an agreement to transfer the United States (U.S.) commercial rights for the anti-epileptic drug (AED) Fycompa? (generic name: perampanel) CIII to Catalyst Pharmaceuticals, Inc. (Headquarters: the United States, “Catalyst Pharmaceuticals”), as well as to provide Catalyst Pharmaceuticals with an exclusive negotiation period for an asset in Eisai’s epilepsy pipeline. Eisai will maintain its rights to Fycompa in countries and regions outside the U.S. and continue to contribute to patients with epilepsy. Closing of the transaction is contingent on completion of review under antitrust laws in the U.S.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that Eisai and Washington University School of Medicine in St. Louis have entered into a comprehensive research collaboration agreement aiming to create potential novel treatments for neurodegenerative disorders, including Alzheimer’s disease (AD) and Parkinson’s disease (PD).
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that new study results on its in-house discovered and developed anticancer agent eribulin mesylate (HALAVEN?, “eribulin”) will be presented during the 2022 San Antonio Breast Cancer Symposium (SABCS), which is taking place virtually and in-person in San Antonio, Texas from December 6-10.
