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Press release
2023年01月27日 08時30分
Source:
Eisai
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
東京, 2023年01月27日 - (JCN Newswire) - 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、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。
米国において、レカネマブは、2023 年 1 月 6 日に米国食品医薬品局（FDA）により AD 治療薬として迅速承認を取得し、同日、臨床第III相Clarity AD 検証試験の結果に基づくフル承認に向けた生物製剤承認一部変更申請（supplemental Biologics License Application：sBLA）を提出しました。日本においても、同年 1 月 16 日に製造販売承認申請を医薬品医療機器総合機構（PMDA）に提出しました。中国においては、2022 年 12 月に中国の国家薬品監督管理局（NMPA）に BLA のデータ提出を開始しました。
レカネマブについて、エーザイは、開発および薬事申請をグローバルに主導し、エーザイの最終意思決定権のもとで、エーザイとバイオジェンが共同商業化・共同販促を行います。
本リリースの詳細は下記をご参照ください。
https://www.eisai.co.jp/news/2023/pdf/news202311pdf.pdf
概要：エーザイ株式会社
詳細は www.eisai.co.jp をご覧ください。
Source: Eisai
セクター: バイオテック
Copyright ©2024 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
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