Tag: Eisai’s

Japan – Eisai’s Antiepileptic Drug Fycompa Injection Formulation Launched In Japan

Eisai Co., Ltd. announced today that the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa (perampanel hydrate) for intravenous (IV) infusion has been launched in Japan. The injection formulation of Fycompa received manufacturing and marketing approval on January 18, 2024 and was included in the Japan’s National Health Insurance (NHI) Drug Price List today. Fycompa is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories. The agent is a selective, noncompetitive AMPA receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Two oral formulations of ... Read more

Japan – Eisai’s Sales Subsidiary Collaborates with Ministry of Public Health (MOPH) in Thailand

Eisai Co., Ltd. announced today that its Thai sales subsidiary Eisai (Thailand) Marketing Co., Ltd., (Eisai Thailand) has made an agreement to collaborate with the Department of Medical Services (DMS), Ministry of Public Health (MOPH) of Thailand to further enhance the access to treatments for dementia including Alzheimer’s disease (AD) in Thailand. In Thailand, the number of people suffering from dementia is expected to increase significantly from the current 700 thousand to 2 million by 2050 due to the rapid aging of the population.*1 Dementia and AD are the third leading cause of death among women (7.1% of total deaths) ... Read more

Japan – Eisai’s Initiatives for Developing New Medicines for Neglected Tropical Diseases and Malaria and Commitment for Funding to the 3rd Phase of Global Health Innovative Technology Fund Activities

Eisai Co., Ltd. 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 ... Read more

Japan – FDA Accepts Eisai’s Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBITM (lecanemab-irmb) for the Treatment of Alzheimer’s Disease

Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics License Application (sBLA) for LEQEMBITM (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to a traditional approval. The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023. The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting. LEQEMBI is a humanized immunoglobulin ... Read more

Japan – Eisai’s Sales Subsidiary Collaborates with Thai Life Insurance to Support Access to Treatments for Dementia, Including Alzheimer’s Disease, in Thailand

Eisai Co., Ltd. announced today that its Thai sales subsidiary Eisai (Thailand) Marketing Co. Ltd. (“Eisai Thailand”) made an agreement to collaborate in supporting access to treatments for dementia, including Alzheimer’s disease, in Thailand with Thai Life Insurance Public Company Limited, a leading life insurance company in Thailand. In Thailand, the number of people suffering from dementia is expected to increase significantly from the current 600 thousand to 1.1 million by 2030 due to the rapid aging of the population(1), and the financial burden of the people suffering from dementia, including Alzheimer’s disease, and their families due to care is ... Read more