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Eisai
Press Release
Eisai Completes Rolling Submission to US FDA for LEQEMBI(R) (lecanemab-irmb) Biologics License Application for Subcutaneous Maintenance Dosing for the Treatment of Early Alzheimer's Disease Under the Fast Track Status
Nov 01, 2024 12:56 JST
Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).
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Eisai Presents Data on Benefits of Long-Term Administration of Dual-Acting Lecanemab at the 17th Clinical Trials for Alzheimer's Disease (CTAD) Conference
Oct 31, 2024 12:56 JST
Eisai Co., Ltd. and Biogen Inc. announced today that the latest findings for lecanemab-irmb (U.S. brand name: LEQEMBI(R)), an anti-amyloid beta (Aβ) protofibril* antibody for the treatment of early Alzheimer's disease (AD), were presented at the Clinical Trials for Alzheimer's Disease Conference (CTAD), held in Madrid, Spain, and virtually.
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Eisai Presents Latest Clinical Findings Suggesting Inhibition of Tau Propagation by Anti-MTBR Tau Antibody E2814 at the 17th Clinical Trials on Alzheimer's Disease Conference (CTAD)
Oct 31, 2024 10:33 JST
Eisai Co. Ltd announced today that the latest findings on anti-MTBR (microtubule binding region) tau antibody E2814 were presented at the 17th annual Clinical Trials on Alzheimer's Disease (CTAD) conference, held in Madrid, Spain, and virtually.
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A Joint Regional Cohort Study by Shimadzu, Eisai, Oita University, and Usuki City Medical Association
Oct 17, 2024 19:01 JST
Shimadzu Corporation, Eisai Co., Ltd., Oita University, and Usuki City Medical Association have demonstrated the utility of blood biomarkers in predicting the accumulation of amyloid beta (Abeta)(1) in the brain, a noted cause of Alzheimer's disease(2), in a cohort study conducted in Usuki City, Oita from November 2022.
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Update on Regulatory Review of Lecanemab for Early Alzheimer's Disease in Australia
Oct 17, 2024 14:59 JST
Eisai Co., Ltd. and Biogen Inc. announced today that the Therapeutic Goods Administration (TGA) of Australia issued a public statement about the initial decision not to register the humanized anti-solubleaggregated amyloid-beta (Abeta) monoclonal antibody lecanemab for the treatment of patients with mild cognitive impairment (MCI)due to Alzheimer's disease (AD) and mild AD dementia.
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Amyotrophic Lateral Sclerosis Treatment "Rozebalamin(R) for Injection 25 mg" Receives The Good Design Award 2024 for Light- Proof Vial Packaging
Oct 16, 2024 18:14 JST
Eisai Co., Ltd. announced today that amyotrophic lateral sclerosis (ALS) treatment "Rozebalamin(R) for Injection 25 mg" (mecobalamin) has received the Good Design Award 2024 (by the Japan Institute of Design Promotion) for its light-proof vial packaging.
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"Urece Tablets" (Dotinurad) Approved In Thailand For Gout And Hyperuricemia
Oct 08, 2024 13:00 JST
Eisai Co., Ltd. announced today that it has received approval for "URECE Tablets" (dotinurad) in Thailand as a treatment for gout and hyperuricemia.
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Eisai Commences Business Activities At New Pharma Sales Subsidiary In Saudi Arabia
Oct 02, 2024 10:28 JST
Eisai Co., Ltd. announced today that fully-fledged operations and business activities have begun at Eisai Pharmaceuticals Single Person Limited Liability Company (Eisai Saudi Arabia), a pharmaceutical sales subsidiary recently established in Riyadh in the Kingdom of Saudi Arabia (Saudi Arabia).
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Rozebalamin(R) for Injection 25 mg (Mecobalamin) Approved in Japan for Amyotrophic Lateral Sclerosis
Sep 24, 2024 15:06 JST
Eisai Co., Ltd. announced today that it has obtained manufacturing and marketing authorization approval for amyotrophic lateral sclerosis (ALS) treatment "Rozebalamin for Injection 25 mg" (mecobalamin) in Japan as a treatment for slowing progression of functional impairment in amyotrophic lateral sclerosis.
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Anticancer Agent "Tasfygo(R) Tablets 35mg" (Tasurgratinib Succinate) Approved in Japan for Biliary Tract Cancer with FGFR2 Gene Fusions or Rearrangements
Sep 24, 2024 14:01 JST
Anticancer Agent "Tasfygo(R) Tablets 35mg" (Tasurgratinib Succinate) Approved in Japan for Biliary Tract Cancer with FGFR2 Gene Fusions or Rearrangements
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LENVIMA(R) (lenvatinib) Plus KEYTRUDA(R) (pembrolizumab) in Combination With Transarterial Chemoembolization (TACE) Significantly Improved Progression-Free Survival Compared to TACE Alone in Patients With Unresectable, Non-Metastatic Hepatocellular Carcinoma (HCC)
Sep 17, 2024 09:08 JST
These late-breaking data were presented for the first time on September 14 (Central European Summer Time) during a Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2024 (Presentation #LBA3).
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Eisai Accelerates Progress in Oncology Research with New Data at ESMO Congress 2024
Sep 05, 2024 15:59 JST
Eisai Co., Ltd. announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the European Society for Medical Oncology (ESMO) Congress 2024, which is taking place virtually and in-person in Barcelona, Spain from September 13 to 17.
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Eisai Announces Status Relating to Acquisition of Own Shares
Sep 02, 2024 14:12 JST
Eisai Co., Ltd. announced today that it has acquired its own shares based on Article 40 of its Articles of Incorporation pursuant to the provisions of Article 459, paragraph 1 of the Companies Act.
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Leqembi (lecanemab) Authorized for Early Alzheimer's Disease in Great Britain
Aug 22, 2024 18:54 JST
Eisai Co., Ltd. and Biogen Inc.announced today that the humanized amyloid-beta(Abeta) monoclonal antibody "Leqembi" (brand name, generic name: lecanemab) has been granted a Marketing Authorization by the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain.
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"LEQEMBI" (Lecanemab) Approved for the Treatment of Alzheimer's Disease in the United Arab Emirates
Aug 14, 2024 08:59 JST
Eisai Co., Ltd. and Biogen Inc. announced today that the Ministry of Health and Prevention in the United Arab Emirates (UAE) has approved humanized anti-soluble aggregated amyloid-beta (Abeta;) monoclonal antibody "LEQEMBI" (lecanemab) for the treatment of Alzheimer's disease (AD).
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Eisai: Update Regarding the Regulatory Status of LEQEMBI Subcutaneous Formulation
Aug 06, 2024 12:15 JST
Eisai Co., Ltd. reconfirmed that the regulatory status for anti-amyloid beta (Aβ) protofibril antibody LEQEMBI (generic name:lecanemab) subcutaneous (SC) autoinjector, explained at the Financial Disclosure Meeting on August 2, 2024, is as follows.
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New Clinical Data Demonstrates Three Years of Continuous Treatment with Dual-Acting LEQEMBI (lecanemab-irmb) Continues to Significantly Benefit Early Alzheimer's Disease Patients Presented at AAIC 2024
Jul 31, 2024 12:59 JST
Eisai Co., Ltd. and Biogen Inc. announced today that the latest findings for lecanemab-irmb (U.S. brand name: LEQEMBI), an anti-amyloid beta (Abeta) protofibril* antibody for the treatment of early Alzheimer's disease (AD), were presented at the Alzheimer's Association International Conference (AAIC) 2024, held in Philadelphia, and virtually.
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Update on Regulatory Review of Lecanemab for Early Alzheimer's Disease in the European Union
Jul 29, 2024 16:59 JST
Eisai Co., Ltd. and Biogen Inc. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Approval (MAA) for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody lecanemab as treatment for early AD (mild cognitive impairment due to Alzheimer?s disease (AD) and mild AD).
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Eisai and EcoNaviSta Enter into Business Alliance Agreement Aimed at Building a Dementia Ecosystem and Commence Collaboration
Jul 25, 2024 09:30 JST
Eisai Co., Ltd. and EcoNaviSta Inc. announced today that they have entered into a business alliance agreement and commenced collaboration with the aim of building an ecosystem in the area of dementia, which is a pressing matter in Japan's super-aging society.
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Eisai to Present Dual-Acting Lecanemab Three-Year Efficacy and Safety Data and Discuss Long-Term Outcomes of Continued Treatment at the Alzheimer's Association International Conference 2024
Jul 23, 2024 19:23 JST
The conference will be held in Philadelphia and virtually from July 28 to August 1, 2024. Eisai will present data and research in four (4) oral and 15 poster presentations at the meeting and will host two (2) sessions on lecanemab.
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"LEQEMBI" (Lecanemab) Approved for the Treatment of Alzheimer's Disease in Israel
Jul 12, 2024 11:56 JST
Eisai Co., Ltd. and Biogen Inc. announced today that humanized anti-soluble aggregated amyloid-beta (Abeta) monoclonal antibody "LEQEMBI" (generic name: lecanemab) has been approved in Israel as a treatment of Alzheimer's disease (AD).
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LEQEMBI (Lecanemab) Approved for the Treatment of Alzheimer's Disease in Hong Kong
Jul 11, 2024 09:00 JST
Eisai Co., Ltd. and Biogen Inc. announced today that the Department of Health in HongKong has approved humanized anti-soluble aggregated amyloid-beta (Abeta;) monoclonal antibody "LEQEMBI" (brand name in Hong Kong: generic name: lecanemab) for treatment of Alzheimer's disease (AD).
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Eisai Announces Move to Solo Development and Commercialization of Farletuzumab Ecteribulin (FZEC) Antibody Drug Conjugate (ADC)
Jul 02, 2024 12:01 JST
Eisai Co., Ltd. announced today that it has agreed to end its global strategic collaboration with Bristol Myers Squibb for the co-development and co-commercialization of farletuzumab ecteribulin (FZEC), formerly known as MORAb-202, a folate receptor alpha (FRα)-targeting antibody drug conjugate (ADC) due to ongoing portfolio prioritization efforts within Bristol Myers Squibb.
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Eisai: "LEQEMBI" (Lecanemab) for the Treatment of Alzheimer's Disease Launched in China
Jun 28, 2024 14:57 JST
China is the third country to launch LEQEMBI following the United States and Japan.
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Eisai Continues Contract for FY2024 Dementia Examination Project by Tokyo Bunkyo City
Jun 21, 2024 14:35 JST
Eisai Co., Ltd. announced today that the company has achieved the pre-set performance indicators in FY2023 for the dementia examination project in Bunkyo City, Tokyo, which the company has been commissioned to conduct in order to raise awareness of dementia and promote early detection, and will continue the commission for this project in FY2024.
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FDA Accepts Eisai's Filing of LEQEMBI (lecanemab-irmb) Supplemental Biologics License Application for IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease
Jun 10, 2024 17:50 JST
Eisai Co., Ltd. and Biogen Inc. announced today that that the U.S. Food and Drug Administration (FDA) has accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly lecanemab-irmb (U.S. brand name: LEQEMBI) intravenous (IV) maintenance dosing.
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Eisai Named to List of The Time 100 Most Influential Companies
Jun 03, 2024 16:08 JST
TIME reveals the TIME100 Most Influential Companies list, highlighting companies making an extraordinary impact around the world.
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Eisai Strengthens Venture Investment Business Aimed at Accelerating Drug Discovery Innovation and Establishment of Ecosystem Platform
Jun 03, 2024 14:22 JST
Eisai Co., Ltd. announced today that the company decided to strengthen and continue its venture investment business, which launched in 2019, with the aim of discovering innovative technologies and services, supporting venture businesses with such technologies and partnering with those businesses in the future, so as to accelerate drug discovery innovation and the establishment of the ecosystem platform.
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LEQEMBI (lecanemab) Approved for the Treatment of Alzheimer's Disease in South Korea
May 28, 2024 14:19 JST
Eisai Co., Ltd. and Biogen Inc. announced today that the Ministry of Food and Drug Safety (MFDS) in South Korea has approved humanized anti-soluble aggregated amyloid-beta (Abeta) monoclonal antibody "LEQEMBI" (lecanemab) for treatment in adult patients with mild cognitive impairment due to Alzheimer's disease (AD) or mild AD (early AD).
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