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| Press Releases |
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| Monday, June 12, 2023 |
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エーザイ、米国FDA諮問委員会は全会一致でアルツハイマー病治療薬「LEQEMBI(R)」(レカネマブ)の臨床上のベネフィットを支持 |
| エーザイ株式会社(本社:東京都、代表執行役CEO:内藤晴夫、以下 エーザイ)とバイオジェン・インク(Nasdaq:BIIB、本社:米国マサチューセッツ州ケンブリッジ、CEO:Christopher A. Viehbacher、以下 バイオジェン)は、このたび、米国食品医薬品局(FDA)の末梢・中枢神経系薬物諮問委員会(Peripheral and Central Nervous System Drugs Advisory Committee、以下 本諮問委員会)が開催され、「LEQEMBI(R)」注射100 mg/mL溶液(一般名:レカネマブ)の臨床第III相Clarity AD検証試験の結果が、本剤の臨床上のベネフィットを示すエビデンスであることが、全会一致で支持されましたのでお知らせします。 more info >> |
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| Thursday, June 8, 2023 |
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Eisai Files Marketing Authorization Application for Lecanemab as Treatment For Early Alzheimer's Disease in South Korea |
| This application is the first application for lecanemab in Asia outside of Japan and China. Eisai plans to submit additional applications in other Asian countries. more info >> |
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エーザイ、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、韓国において早期アルツハイマー病に係る適応で新薬承認を申請 |
| エーザイ株式会社(本社:東京都、代表執行役CEO:内藤晴夫、以下 エーザイ)とバイオジェン・インク(Nasdaq:BIIB、本社:米国マサチューセッツ州ケンブリッジ、CEO:Christopher A. Viehbacher、以下 バイオジェン)は、このたび、エーザイが抗アミロイド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(R)」)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)に係る適応で、韓国食品医薬品安全処(MFDS)に新薬承認申請を行いましたのでお知らせします。 more info >> |
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| Friday, June 2, 2023 |
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Eisai to Present Latest Data on Lemborexant at the 37th Annual Sleep 2023 Meeting |
| Eisai Co., Ltd. announced a total of eight poster presentations, including the latest data on its in-house discovered orexin receptor antagonist lemborexant (product name: DAYVIGO), will be given at the 37th annual meeting of the Associated Professional Sleep Societies (SLEEP 2023), to be held from June 3 to 7, 2023 in Indianapolis, IN, the United States. more info >> |
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| Friday, May 26, 2023 |
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LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma |
| These data will be presented on Monday, June 5 at 11:54 a.m. Central Daylight Time during an oral abstract session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #4502). more info >> |
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| Thursday, May 25, 2023 |
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Eisai's Initiatives for Developing New Medicines for Neglected Tropical Diseases and Malaria |
| Eisai Co., Ltd. has announced that it will grant a total of 625 million yen to the Global Health Innovative Technology Fund ("GHIT Fund") to fund the third phase of its activities, which will take place in the five-year period from FY2023 to FY2027. more info >> |
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| Wednesday, May 24, 2023 |
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Eisai Delivers New Data and Highlights Continued Progress of Oncology Portfolio and Pipeline at ASCO 2023 |
| Eisai Co., Ltd. announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO23), which is taking place virtually and in-person in Chicago, Illinois from June 2 to 6. more info >> |
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米国臨床腫瘍学会年次総会におけるエーザイのがん領域の製品・開発品に関する発表について |
| エーザイ株式会社(本社:東京都、代表執行役CEO:内藤晴夫)は、2023年6月2日から6日まで米国イリノイ州シカゴおよびバーチャル形式で開催される「米国臨床腫瘍学会(American Society of Clinical Oncology:ASCO)年次総会」(2023 ASCO Annual Meeting)において、当社のがん領域における製品・開発品の様々ながん種における最新知見を発表することをお知らせします。 more info >> |
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| Saturday, May 20, 2023 |
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Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease in Great Britain |
| Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has submitted a Marketing Authorization Application (MAA) for lecanemab, an investigational anti-amyloid beta (Aβ) 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 in the brain, to the UK Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain. more info >> |
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| Monday, May 22, 2023 |
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エーザイ、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、英国(北アイルランドを除く)において早期アルツハイマー病に係る販売承認申請を提出 |
| エーザイ株式会社とバイオジェン・インクは、このたび、英国(北アイルランドを除く)において、 エーザイが抗アミロイドβ(Aβ)プロトフィブリル抗体レカネマブ(一般名)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)を、英国医薬品医療製品規制庁(MHRA)に提出したことをお知らせします。 more info >> |
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