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Press release
2018年05月25日 10時00分
Source:
Eisai
エーザイ、MSDとの「レンバチニブ」の切除不能な肝細胞がんに係る承認申請の米国FDAによる審査終了目標日延長について
東京, 2018年05月25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Merck & Co., Inc. Kenilworth, N.J., U.S.A.(北米以外ではMSD)は、このたび、米国におけるキナーゼ阻害剤「レンビマ(R)」(一般名:レンバチニブメシル酸塩)の「切除不能な肝細胞がん」に係る適応追加申請について、米国食品医薬品局(Food and Drug Administration: FDA)によるPDUFA(Prescription Drug User Fee Act)アクション・デート(審査終了目標日)が延長されたことをお知らせします。
FDAより、本申請の審査に追加の時間が必要であり、本アクションデートを延長する旨の連絡がありました。FDAによると、審査は従来のPDUFAアクション・デート(2018年5月24日)の3カ月後となる2018年8月24日までに完了する予定です。3カ月はFDAの延長期間として標準的なものです。
エーザイは申請者として、引き続きFDAの審査に協力してまいります。
「レンビマ」は、米国において「局所再発又は転移性、進行性、放射性ヨウ素治療抵抗性分化型甲状腺がん」、および「血管新生阻害薬の前治療歴を有する進行性腎細胞がんに対するエベロリムスとの併用療法」の適応で承認を取得しています。
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/2018/news201839.html
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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