Eisai Press Release


Eisai Receives Approval for Partial Label Change for Vascular Embolization Device DC Bead
Sep 03, 2018 14:50 JST
Eisai Co., Ltd. announced that it has received approval for a partial label change for the vascular embolization device DC Bead (specially controlled medical device) in Japan.
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Eisai's LENVIMA (LENVATINIB) Capsules Approved for First-Line Treatment of Unresectable Hepatocellular Carcinoma (HCC) in South Korea
Aug 30, 2018 09:36 JST
Eisai Co., Ltd. announced that its South Korea subsidiary Eisai Korea Inc. received approval for the kinase inhibitor LENVIMA (lenvatinib mesylate) as a single agent for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) from the Ministry of Food and Drug Safety (MFDS) in South Korea.
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Biogen and Eisai Report Data from Long-Term Extension Phase 1b Study of Investigational Alzheimer's Disease Treatment Aducanumab
Aug 29, 2018 10:25 JST
Biogen and Eisai Co., Ltd. announced results from a recent analysis of the ongoing long-term extension (LTE) Phase 1b study of aducanumab, an investigational treatment for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD dementia.
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Eisai: Long-Term Cardiovascular Outcomes Data for Anti-Obesity Agent BELVIQ
Aug 28, 2018 09:11 JST
The average change in weight from baseline was -4.2 kg with BELVIQ and -1.4 kg with placebo, translating to a 2.8 kg greater net weight loss with BELVIQ (nominal p-value<0.001).
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Eisai: European Commission Grants Marketing Authorization for LENVIMA (Lenvatinib)
Aug 23, 2018 08:00 JST
This is the first new first-line treatment option for advanced or unresectable HCC to be approved in Europe in approximately 10 years.
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Eisai Signs Collaboration Agreement for Anti-Obesity Agent Lorcaserin in China to CY Biotech
Jul 31, 2018 14:13 JST
Under this agreement, Eisai will supply CYB with lorcaserin. Eisai will receive a one-time contractual payment and milestone payments dependent upon acquisition of regulatory approval.
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Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Announce U.S. FDA Grants Breakthrough Therapy Designation for LENVIMA
Jul 31, 2018 10:27 JST
The LENVIMA/KEYTRUDA combination therapy is being jointly developed by Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. as part of the strategic collaboration announced in March 2018.
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Eisai and Biogen Announce Detailed Results of Phase II Clinical Study of BAN2401 in Early Alzheimer's Disease at AAIC 2018
Jul 26, 2018 10:34 JST
Eisai Co., Ltd. and Biogen Inc. announced detailed results from the Phase II study (Study 201) with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer's disease as part of Session DT-01 "Recent Developments in Therapeutics" at AAIC 2018 being held in Chicago, Illinois, United States on July 25.
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Eisai and Biogen Present Detailed Results from Phase II Clinical Study of Elenbecestat in MCI and Mild to Moderate Alzheimer's Disease at AAIC 2018
Jul 26, 2018 08:01 JST
Eisai Co., Ltd. and Biogen Inc. announced detailed results from a Phase II clinical study (Study 202) of the investigational oral BACE inhibitor elenbecestat (development code: E2609) at the AAIC 2018 being held in Chicago, Illinois, United States, from July 22 to 26, 2018.
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Latest Data on Eisai's Alzheimer's Disease / Dementia Pipeline to be Presented at Alzheimer's Association International Conference (AAIC) 2018
Jul 19, 2018 09:38 JST
Eisai Co., Ltd. announces today that a total of 13 presentations highlighting results from a Phase II clinical study (Study 201) of the anti-amyloid beta (Abeta) protofibril antibody BAN2401 and a Phase II clinical study (Study 202) will be given at the Alzheimer's Association International Conference (AAIC) 2018, in Chicago.
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Eisai: Positive Topline Results Obtained from Large-Scale Cardiovascular Outcomes Trial of Anti-Obesity Agent BELVIQ
Jul 18, 2018 11:04 JST
This study was conducted at over 400 sites in eight countries including the United States in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group, and is the largest cardiovascular outcome trial conducted to date for a weight loss medication.
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Eisai: Oral Antifungal Agent Nailin Capsules 100mg to be Launched in Japan
Jul 11, 2018 15:32 JST
Sato Pharmaceutical Co., Ltd. and Eisai Co., Ltd. will launch the oral antifungal agent NAILIN Capsules 100mg in Japan on July 27, 2018.
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Eisai: Oral Presentation on Phase II Clinical Study Results of BAN2401 to be Presented at Alzheimer's Association International Conference (AAIC) 2018
Jul 10, 2018 10:14 JST
Eisai Co., Ltd. announces today that the results of the Phase II clinical study (Study 201) of the anti-amyloid beta (Abeta) protofibril antibody BAN2401 will be presented in an oral session at the Alzheimer's Association International Conference (AAIC) 2018 held in Chicago.
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Eisai: Results from Two Phase 3 Clinical Trials of Chronic Constipation Treatment "GOOFICE 5mg Tablet" Published in The Lancet Gastroenterology & Hepatology
Jul 09, 2018 14:07 JST
The 2-week double-blind clinical trial was a placebo-controlled, randomized, double-blind trial with 133 Japanese patients with chronic constipation.
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Eisai and Biogen Announce Positive Topline Results of the Final Analysis for BAN2401 At 18 Months
Jul 06, 2018 09:31 JST
Eisai Co., Ltd. and Biogen Inc. announced positive topline results from the Phase II study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer's disease.
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Eisai Listed for 17th Consecutive Year in FTSE4GOOD Index Series
Jul 04, 2018 17:18 JST
Eisai Co., Ltd. announced today that it has been included in the FTSE4Good Index Series for the 17th consecutive year since its initial inclusion in 2002.
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Eisai to Give Oral Presentation on Results of Phase III Head-to-Head Clinical Study of Lemborexant in Insomnia Disorder
Jul 02, 2018 15:36 JST
The symposium will report on the latest data on lemborexant from non-clinical research and clinical studies relating to insomnia, including the results of SUNRISE 1.
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Eisai Selected for Membership in MSCI Japan Empowering Women Index (WIN)
Jun 22, 2018 10:58 JST
Eisai Co., Ltd. announced today that it has been selected for the first time for membership in the MSCI Japan Empowering Women Index (WIN), an index developed for environmental, social and governance (ESG) investment.
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AbbVie and Eisai Announce the Launch of HUMIRA for Subcutaneous Injection 20 mg Syringe 0.2 mL
Jun 21, 2018 09:51 JST
AbbVie GK and Eisai Co., Ltd. announced that HUMIRA for Subcutaneous Injection 20 mg Syringe 0.2 mL, a new pediatric formulation of HUMIRA, a fully human anti-TNF-alpha monoclonal antibody formulation, has been launched today after being listed in the National Health Insurance reimbursement price list on June 15.
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Eisai: Industry-Academia-Government Joint Development Agreement Concerning Nucleic Acid Drug Discovery Research
Jun 14, 2018 09:11 JST
Eisai Co., Ltd. announced today that its research subsidiary KAN Research Institute, Inc. has entered into an industry-academia-government joint research agreement with six joint research organizations concerning the "nucleic drug discovery research using novel nucleic acid synthesis and delivery technologies" research project represented by KAN.
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Eisai to Establish New Research Facility "Eisai Center for Genetics Guided Dementia Discovery" in Cambridge, Massachusetts, USA
Jun 13, 2018 11:53 JST
Eisai Co., Ltd. has announced that it has decided to establish the Eisai Center for Genetics Guided Dementia Discovery (G2D2), a new exploratory research facility focused on immuno-dementia based on human genetics, aimed at innovative drug discovery in the field of dementia, in Cambridge, Massachusetts, the United States.
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AbbVie and Eisai Announce the Launch of HUMIRA Pen, an Auto-Injector Formulation for Fully Human Anti-TNF-alpha Monoclonal Antibody HUMIRA
Jun 11, 2018 11:44 JST
The newly launched pen-type auto-injector devices were developed to simplify the operation and reduce the burden on patients when performing self-injection.
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Eisai: Positive New Data on Investigational Lemborexant Presented at 32nd Annual SLEEP Meeting
Jun 06, 2018 11:16 JST
Eisai Co., Ltd. and Purdue Pharma L.P. presented the results of two key Phase I clinical studies (Study 108 and Study 106) of their investigational sleep/wake regulation agent lemborexant at the 32nd Annual Meeting of the Associated Professional Sleep Societies (SLEEP 2018), from June 2 to 6 in Baltimore, Maryland, the United States.
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Eisai: PhaseII Clinical Study of Elenbecestat Demonstrate Safety and Tolerability in MCI and Mild to Moderate Alzheimer's Disease at 18-Months
Jun 05, 2018 09:08 JST
Eisai Co., Ltd. and Biogen Inc. announced today that elenbecestat was generally safe and well tolerated in a Phase II clinical study (Study 202) of the oral BACE (beta amyloid cleaving enzyme) inhibitor elenbecestat (development code: E2609) conducted in the United States, and the results demonstrated a statistically significant difference in amyloid beta (AB) levels in the brain measured by amyloid-PET (positron emission tomography).
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Eisai and Merck Announce Data at 2018 ASCO Annual Meeting
Jun 04, 2018 20:10 JST
The data are included in presentations at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from June 1-5. LENVIMA and KEYTRUDA are not approved for use in combination in any cancer types today.
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U.S. FDA Designates for Priority Review of Eisai's Supplemental New Drug Application for Antiepileptic Drug Fycoma
May 31, 2018 12:33 JST
Eisai Co., Ltd. has announced the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Eisai's antiepileptic drug (AED) Fycompa (perampanel).
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Eisai: PIII Clinical Study Data on Chronic Constipation Treatment "GOOFICE 5mg Tablet" will be Presented at DDW2018
May 28, 2018 16:06 JST
Eisai Co., Ltd., Eisai's subsidiary for gastrointestinal diseases EA Pharma Co., Ltd. and Mochida Pharmaceutical Co., Ltd. announce that an oral presentation on PIII clinical study data on "GOOFICE 5mg Tablet".
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Eisai: Potent New Mechanism of Action for Treatment of Inflammatory Bowel Disease
May 25, 2018 14:00 JST
This novel mechanism of action elucidated is expected to lead to value enhancement and acceleration of the development of E6007 which aims to provide a new remedy for IBD patients.
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Eisai and Merck & Co. Provide Update on Supplemental New Drug Application (sNDA) for Lenvatinib
May 25, 2018 10:43 JST
The FDA has indicated that the extension of the Prescription Drug User Fee Act (PDUFA) date is needed to allow additional time for review of the application.
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