エーザイ、E2082の臨床第I相試験（治験）における死亡例の発生について

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2019年07月31日 08時00分

Source: Eisai

エーザイ、E2082の臨床第I相試験（治験）における死亡例の発生について

東京, 2019年07月31日 - (JCN Newswire) - 当社が日本国内で実施していた健康成人を対象とした臨床第I相試験（治験）において、2019 年6 月に、1 名の被験者様が治験薬の投与を完了後にお亡くなりになりました。被験者様のご冥福をお祈り申し上げると共に、ご遺族様には謹んでお悔やみ申し上げます。

今回の治験で用いた治験薬は、神経系に作用する薬剤として当社が開発を進めておりました E2082です。

治験薬と被験者様の死亡の因果関係は不明であり、また、これまでに本治験において他の被験者様に重篤な副作用は報告されておりません。なお、E2082 の治験での投与は既にすべて中止しております。

当社は、速やかに厚生労働省に本事案を報告の上、同省の調査に積極的に協力しております。

当社は、被験者様がお亡くなりになったことを極めて重く受け止め、引き続き安全性に十分配慮し、高い倫理観を持って、医薬品の研究開発を行ってまいります。

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/2019/pdf/news201958pdf.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

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