Peripheral and Central Nervous System Drugs Advisory Committee voted based on data from large global confirmatory Phase 3 Clarity AD clinical trial in patients living with early Alzheimer’s disease
The PDUFA action date for traditional approval of LEQEMBI has been set for July 6, 2023, with designation of priority review
LEQEMBI received accelerated approval from the FDA for the treatment of early Alzheimer’s disease on January 6, 2023

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today a total of eight poster presentations, including the latest data on its in-house discovered orexin receptor antagonist lemborexant (product name: DAYVIGO?), will be given at the 37th annual meeting of the Associated Professional Sleep Societies (SLEEP 2023), to be held from June 3 to 7, 2023 in Indianapolis, IN, the United States.

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) has announced that it will grant a total of 625 million yen to the Global Health Innovative Technology Fund (“GHIT Fund”) to fund the third phase of its activities, which will take place in the five-year period from FY2023 to FY2027. The GHIT Fund is a public-private partnership, co-established in April 2013 by partners such as Japanese pharmaceutical companies (including Eisai), the Japanese government, and the Bill & Melinda Gates Foundation, for the purpose of accelerating development of new medicines to cure infectious diseases in developing and emerging countries by facilitating collaboration between research organizations in Japan and overseas. Eisai has provided a total of 1 billion yen to the first phase (FY2013 – FY2017) and the second phase (FY2018 – FY2022) of the GHIT Fund.

Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted a Marketing Authorization Application (MAA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody, for the treatment of early Alzheimer’s disease with confirmed amyloid pathology in the brain, to the UK Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).

Feng Yanhui, President of Eisai China, visited SINOPHARM Holding Henan Co., Ltd for business research, accompanied by Li Yunlong, VP of Eisai China, Zhao Jianjun, Director of North China Access Department, and Xia Ruiying, Manger of North China Access Department in Eisai China. Chen Zhanyu, Vice President of SINOPHARM Holding and Chairman of SINOPHARM Holding Henan, Zhang Zhaohui, General Manager of SINOPHARM Holding Henan, Xu Hai, Deputy General Manager of SINOPHARM Holding Global Procurement and Supply Chain Service Center , Li Jie, Assistant General Manager of SINOPHARM Holding Henan, and Yang Fan, Director of Supply Chain Business Development Department of SINOPHARM Holding received Feng Yanhui and her delegation.