Eisai Press Release


Eisai: MHLW Grants Orphan Drug Designation in Japan to Mecobalamin Ultrahigh-Dose Formulation with Prospective Indication for Delaying the Progression of Disease and Functional Impairment of ALS
May 27, 2022 11:24 JST
Eisai Co., Ltd. announced today that it has received orphan drug designation for ultrahigh-dose mecobalamin, with a prospective indication for delaying the progression of disease and functional impairment of amyotrophic lateral sclerosis (ALS), by the Ministry of Health, Labour and Welfare (MHLW).
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Eisai Completes Rolling Submission to the U.S. FDA for Biologics License Application of Lecanemab for Early Alzheimer's Disease Under the Accelerated Approval Pathway
May 10, 2022 10:23 JST
Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has completed the rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) under the accelerated approval pathway.
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Eisai Initiates Preparation for New Drug Application, Based on the Results of an Investigator-Initiated Clinical Trial of Ultrahigh-Dose Mecobalamin for Amyotrophic Lateral Sclerosis in Japan
May 10, 2022 10:00 JST
Eisai Co., Ltd. today announced that it has initiated preparation on a New Drug Application for ultrahigh-dose mecobalamin.
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Eisai Announces Acquisition of Arteryex Shares (Making Arteryex a Subsidiary) to Strengthen and Rapidly Expand the Foundation of its Digital Solution Business
Apr 01, 2022 13:05 JST
Eisai Co., Ltd. announced today that Eisai has acquired a majority of the shares issued by Arteryex Inc., a company that plans and develops software related to digital solutions such as provision of medical information platforms, through purchase of shares and subscription of a third-party allocation of common shares, and made it a subsidiary, as of March 31, 2022.
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Eisai: Announcement About an Approval for Additional Indication of Jyseleca, JAK inhibitor
Mar 28, 2022 21:38 JST
Gilead Sciences K.K., Eisai Co., Ltd. and EA Pharma Co., Ltd. announced that Gilead acquired an approval of additional indication of Jyseleca, Janus Kinase (JAK) inhibitor, for the treatment of patients with active moderate-to-severe ulcerative colitis in Japan.
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Eisai: Latest Findings on Lecanemab Presented at AD/PD 2022 Annual Meeting
Mar 22, 2022 09:21 JST
Eisai Co., Ltd. and Biogen Inc. announced today that the latest findings on lecanemab, an investigational anti-amyloid-beta (Abeta) protofibril antibody being developed for the treatment of early Alzheimer's disease (AD), were presented at the Abeta Targeted Therapies in AD 2 Symposium at the 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) March 15-20 in Barcelona, Spain and virtually.
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Eisai: Economic Arrangements of Amendment to Alzheimer's Disease Treatment Collaboration Agreement with Biogen
Mar 15, 2022 12:03 JST
Eisai Co., Ltd. announced the following economic arrangements agreed in the amendment to Alzheimer's disease collaboration agreement with Biogen Inc. separately announced today.
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Biogen and Eisai Amend Collaboration Agreements on Alzheimer's Disease Treatments
Mar 15, 2022 11:00 JST
Biogen Inc. and Eisai Co., Ltd. announced today that the companies have amended their existing collaboration agreement on aducanumab, which is commercialized in the United States as ADUHELM (aducanumab-avwa).
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Eisai to Present New Lecanemab Data Exploring Distinct Mechanism of Action and Clinical Outcomes, Disease State (DSE) Symposium, and Other Pipeline Assets at the AD/PD 2022 Annual Meeting
Mar 11, 2022 11:15 JST
Eisai Co., Ltd. announced today the company will present research from its robust Alzheimer's disease (AD) pipeline, including the latest findings on lecanemab, Eisai's investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of early AD at the AD/PD 2022 International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) from March 15-20 in Barcelona, Spain and virtually.
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Eisai Certified as the 2022 Health and Productivity Management Outstanding Organization (White 500)
Mar 09, 2022 15:06 JST
Eisai Co., Ltd. announced today that it has been certified as the Health and Productivity Management Outstanding Organization in the large enterprise category (White 500) by Japan's Ministry of Economy, Trade and Industry and the Nippon Kenko Kaigi.
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LENVIMA in Combination with KEYTRUDA Approved In Taiwan for the Treatment of Patients with Advanced Endometrial Carcinoma
Mar 07, 2022 12:50 JST
Eisai Co., Ltd. announced today that LENVIMA (generic name: lenvatinib mesylate), the multiple receptor tyrosine kinase inhibitor discovered by Eisai, in combination with Merck & Co., Inc., Kenilworth, N.J., U.S.A.
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Eisai Initiates Submission of Application Data Under the Prior Assessment Consultation System in Japan with the Aim of Obtaining Early Approval for Investigational Anti-Amyloid Beta Protofibril Antibody Lecanemab
Mar 04, 2022 10:05 JST
Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan for the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (BAN2401).
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Eisai: LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Approved in Japan for Radically Unresectable or Metastatic Renal Cell Carcinoma
Feb 25, 2022 16:26 JST
Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA.
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Eisai Receives the Tokyo Governor Prize for Corporate Governance of the Year 2021
Feb 01, 2022 16:43 JST
Eisai Co., Ltd. announced today that it was selected as the winner of the Tokyo Governor Prize for Corporate Governance of the Year 2021, which is an award program organized by the Japan Association of Corporate Directors (JACD).
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Eisai: Lenvima (Lenvatinib) in Combination with Keytruda (Pembrolizumab) Approved in Taiwan for the First-Line Treatment of Patients with Advanced Renal Cell Carcinoma
Jan 31, 2022 08:47 JST
This marks the first approval for LENVIMA which will be used in combination with KEYTRUDA for advanced RCC in Asia.
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Eisai Announces Results and Continued Support of Initiatives for Elimination of Neglected Tropical Diseases
Jan 28, 2022 11:43 JST
Eisai Co., Ltd. announced today that its CEO Haruo Naito participated in the online event entitled "100% COMMITTED to End NTDs" celebrating the 10th anniversary of the London Declaration, an international public-private partnership to eliminate neglected tropical diseases (NTDs), on January 27, 2022.
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Eisai: Update on the Phase 4 ENVISION Confirmatory Study of ADUHELM
Jan 28, 2022 08:40 JST
Biogen Inc. and Eisai Co., Ltd. (Tokyo, Japan) today announced additional details about the Phase 4 post-marketing confirmatory study, ENVISION, of ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use in early Alzheimer's disease, including details of the study's goal for diverse enrollment and primary endpoint.
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Eisai: Results From Pivotal Phase 3 Study 309/KEYNOTE-775 Trial of LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) in Advanced Endometrial Carcinoma
Jan 20, 2022 08:56 JST
Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced the publication of results from the Phase 3 Study 309/KEYNOTE-775 trial in the January 19, 2022 edition of the New England Journal of Medicine.
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Eisai Listed as a Global 100 Most Sustainable Corporation for the Sixth Time
Jan 19, 2022 16:36 JST
Eisai Co., Ltd. announced today that it has been listed in the 2022 Global 100 Most Sustainable Corporations in the World (Global 100), a global ranking by Canada-based media and investment advisory company, Corporate Knights, Inc.
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Eisai's Anti-amyloid Beta Protofibril Antibody Lecanemab Selected as the Background Therapy for the Tau Nexgen Study
Jan 19, 2022 09:06 JST
Eisai Co., Ltd. announced today that the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, has enrolled the first subject in the phase II/III study (Tau NexGen study).
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Eisai to Present Abstracts on Lenvatinib at 2022 ASCO Gastrointestinal Cancers Symposium
Jan 17, 2022 10:44 JST
Eisai Co., Ltd. announced today that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, 'lenvatinib") will be given at the 2022 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI22), taking place in-person in San Francisco, California, and virtually, from January 20 to 22, 2022.
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Eisai to Launch Digital Too "Cogmate" in Taiwan and Hong Kong for Self-Assessment of Brain Performance (Brain Health)
Jan 13, 2022 12:26 JST
Eisai Co., Ltd. announced today that its Taiwanese subsidiary Eisai Taiwan Inc. and Hong Kong subsidiary Eisai (Hong Kong) Co., Ltd. have launched "CogMateTM", a digital tool (non-medical device) for self-assessment of brain performance (brain health).
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Eisai Enters Into Exclusive Licensing Agreement with Roivant Concerning Investigational Anticancer Agent H3B-8800, a Splicing Modulator
Jan 06, 2022 10:09 JST
Eisai Co., Ltd. announced today that it has entered into a License Agreement granting the exclusive rights for global research, development, manufacture and sale of the investigational anticancer agent H3B-8800 to a subsidiary of Roivant Sciences Ltd.
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Investigational Alzheimer's Disease Therapy Lecanemab Granted FDA Fast Track Designation
Dec 24, 2021 08:26 JST
Eisai Co., Ltd. and Biogen Inc. announced today that lecanemab, an investigational anti-amyloid beta (Abeta) 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).
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Biogen Announces Reduced Price for Aduhelm to Improve Access For Patients With Early Alzheimer's Disease In The United States
Dec 21, 2021 09:23 JST
Eisai Co., Ltd. announced today that, effective January 1, 2022, Biogen will reduce the wholesale acquisition cost (WAC) of ADUHELM (aducanumab-avwa) 100 mg/mL injection for intravenous use in the United States by approximately 50%. For a patient of average weight (74 kg), the yearly cost at the maintenance dose (10 mg/kg) will be $28,200.
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Eisai Enters into Commercialization and Distribution Agreement with Gilead for JAK Inhibitor Filgotinib in Asia
Dec 20, 2021 12:35 JST
Eisai Co., Ltd. today announced it has entered into an agreement with Gilead Sciences, Inc. for the commercialization and distribution of filgotinib.
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Eisai to Present Abstracts on Oncology Products And Pipeline at 44th Annual San Antonio Breast Cancer Symposium
Dec 06, 2021 11:30 JST
Eisai Co., Ltd. announced today that presentations on a series of abstracts highlighting updates on its in-house discovered eribulin mesylate (product name: Halaven, halichondrin class microtubule dynamics inhibitor, "eribulin"), MORAb-202, an antibody drug conjugate (ADC), and H3B-6545 (selective estrogen alpha receptor covalent antagonist).
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Eisai and FCNT Enter Into Business Alliance Aiming to Support People Living with Dementia and to Prevent Dementia
Nov 30, 2021 09:13 JST
Eisai Co., Ltd. and FCNT LIMITED announced today that both companies have entered into a business alliance agreement aiming to support people living with dementia and to prevent dementia, through developing solutions for maintaining brain performance.
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Eisai to Present Latest Data on Perampanel and E2730 at the 75th American Epilepsy Society Annual Meeting
Nov 30, 2021 08:56 JST
Eisai Co., Ltd. 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 at the 75th American Epilepsy Society Annual Meeting (AES2021), to be held in Chicago, Illinois and virtually from December 3 to 7, 2021.
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