First Approval in Japan for the LENVIMA Plus KEYTRUDA Combination
TOKYO and CAMBRIDGE, Mass, Dec. 24, 2021 – Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, “Biogen”) announced today that lecanemab, an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of early Alzheimer’s disease (AD), was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). FDA granted Breakthrough Therapy designation for lecanemab in June of 2021. Breakthrough Therapy designation and Fast Track designation are two FDA programs that are intended to facilitate and expedite development of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition such as AD and provide opportunities for frequent interactions with the FDA.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) today announced it has entered into an agreement with Gilead Sciences, Inc. (Headquarters: Foster City, California, “Gilead”) for the commercialization and distribution of filgotinib (generic name, product name: Jyseleca? ), an oral, JAK1 preferential inhibitor for indications of rheumatoid arthritis (RA), ulcerative colitis, and Crohn’s disease in Asia (South Korea, Chinese Taiwan, HKSA and Singapore). In December 2019, Eisai signed a partnership agreement with Gilead Sciences K.K. (Headquarters: Tokyo), a Japanese subsidiary of Gilead, for the distribution and co-promotion of filgotinib in Japan.
Developing solutions such as smartphones equipped with the brain health check tool “NouKNOW?”
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the company will conduct a total of 42 poster presentations, including the latest data on its in-house discovered and developed anti-epileptic agent (AED) perampanel (product name: Fycompa?) and in-house discovered and developed E2730, an investigational novel small compound for AED and the treatment for neurological diseases, at the 75th American Epilepsy Society Annual Meeting (AES2021), to be held in Chicago, Illinois and virtually from December 3 to 7, 2021.
First Combination of Tyrosine Kinase Inhibitor with Immunotherapy Approved in Europe for Adult Patients With Advanced or Recurrent Endometrial Carcinoma With Disease Progression on or Following Prior Treatment With a Platinum-Containing Therapy in Any Setting and Who Are Not Candidates for Curative Surgery or Radiation
Approval Based on Study 309/KEYNOTE-775 Results Demonstrating Statistically Significant Improvements in Overall Survival and Progression-Free Survival Compared With Chemotherapy
Approval Based on Results From CLEAR/KEYNOTE-581 Trial Demonstrating LENVIMA Plus KEYTRUDA Significantly Reduced the Risk of Disease Progression or Death by 61%, With a Median Progression-Free Survival of Nearly Two Years Versus Nine Months for Sunitinib
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that it has been selected for a membership in the Dow Jones Sustainability Asia Pacific Index (DJSI Asia Pacific), the Asia Pacific version of the Dow Jones Sustainability Indices (DJSI), which are a family of premier global indices for socially responsible investment (SRI). This marks Eisai’s eighth selection.
Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) has announced that it has been selected as the winner of the “Most Liked!” IR Award at the 2021 IR Award, hosted by the Japan Investor Relations Association (Chairman: Naoki Izumiya, “JIRA”).
Consistency of Efficacy Assessments Evaluated Across Various Statistical Methods
