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| Monday, January 30, 2023 |
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Lecanemab Receives Priority Review Status in Japan |
| Eisai Co., Ltd. and Biogen Inc. announced today that an application for manufacturing and marketing approval for lecanemab (generic name, U.S. brand name: LEQEMBI), an anti-amyloid-beta (Abeta) protofibril* antibody, in Japan has been designated for Priority Review by the Japanese Ministry of Health, Labour and Welfare (MHLW). more info >> |
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エーザイとバイオジェン、抗アミロイドβプロトフィブリル抗体「レカネマブ」について、日本において優先審査品目に指定 |
| エーザイ株式会社とバイオジェン・インクは、このたび、抗アミロイドβ（Aβ）プロトフィブリル*抗体レカネマブ（一般名、米国ブランド名：LEQEMBI(TM)）の日本における製造販売承認申請について、厚生労働省より優先審査品目に指定されたことをお知らせします。 more info >> |
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| Friday, January 27, 2023 |
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Eisai: Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease Accepted by European Medicines Agency |
| Eisai Co., Ltd. and Biogen Inc. announced today that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for lecanemab, an investigational anti-amyloid beta (Abeta) protofibril* antibody, for the treatment of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease (AD) and mild AD dementia) with confirmed amyloid pathology, for review following a standard timeline. more info >> |
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エーザイとバイオジェン、抗アミロイドβプロトフィブリル抗体「レカネマブ」について早期アルツハイマー病に係る販売承認申請が欧州医薬品庁により受理 |
| エーザイ株式会社とバイオジェン・インクは、このたび、抗アミロイドβ（Aβ）プロトフィブリル抗体レカネマブ（一般名、米国ブランド名：LEQEMBI）について、脳内アミロイド病理が確認された早期アルツハイマー病（アルツハイマー病（AD）による軽度認知障害および軽度認知症）に係る販売承認申請（MAA）が、欧州医薬品庁（EMA）によって受理されたことをお知らせします。今後、標準スケジュールに従って審査が行われます。 more info >> |
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| Thursday, January 19, 2023 |
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Eisai Commences Business Activities at New Pharma Sales Subsidiary in Israel |
| Eisai Co., Ltd. announced today that fully-fledged operations and business activities have begun at Eisai Israel Ltd., a pharmaceutical sales subsidiary recently established in Tel Aviv in the State of Israel (Israel). more info >> |
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Eisai Listed as a Global 100 Most Sustainable Corporation for The Seventh Time Highest Ranked Global Pharmaceutical Company |
| Eisai Co., Ltd. announced that it has been listed in the 2023 Global 100 Most Sustainable Corporations in the World (Global 100), a global ranking by Canada-based media and investment advisory company, Corporate Knights, Inc. more info >> |
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エーザイ、イスラエルの医薬品販売子会社が事業活動を開始 |
| エーザイ株式会社（本社：東京都、代表執行役CEO：内藤晴夫）は、このたび、イスラエルのテルアビブ市に設立した医薬品販売会社「Eisai Israel Ltd.」（以下、 エーザイ・イスラエル）が本格稼働し、事業活動を開始したことをお知らせします。 more info >> |
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| Wednesday, January 18, 2023 |
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Eisai Aims to Advance Gastrointestinal Cancer Treatment with Research Across Multiple Tumor Types at ASCO GI 2023 |
| Eisai Co., Ltd. announced today the presentation of research across various types of gastrointestinal cancers during the 2023 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI23), which is taking place in-person in San Francisco, California and virtually from January 19-21. more info >> |
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| Monday, February 22, 2021 |
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Eisai: MHLW Grants Orphan Drug Designation in Japan to Novel FGF Receptor Selective Tyrosine Kinase Inhibitor E7090 |
| Eisai Co., Ltd. announced that it has received orphan drug designation for a prospective indication for unresectable biliary tract cancer with FGFR2 gene fusion by the Ministry of Health, Labour and Welfare, Japan (MHLW) for its in-house discovered fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor E7090, which is currently under development as an orally available novel anti-cancer agent. more info >> |
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エーザイ、新規線維芽細胞増殖因子（FGF）受容体選択的チロシンキナーゼ阻害剤E7090が日本においてFGFR2融合遺伝子を有する切除不能な胆道がんを予定される効能・効果として厚生労働省より希少疾病用医薬品に指定 |
| エーザイ株式会社（本社：東京都、代表執行役CEO：内藤晴夫）は、このたび、当社が創製し、経口投与可能な新規抗がん剤として開発中の線維芽細胞増殖因子（FGF）受容体（FGFR1、FGFR2、FGFR3）選択的チロシンキナーゼ阻害剤E7090について、FGFR2融合遺伝子を有する切除不能な胆道がんを予定される効能・効果として、厚生労働省より希少疾病用医薬品（オーファンドラッグ）に指定されたことをお知らせします。 more info >> |
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