エーザイ、アデュカヌマブのブラジル・カナダ・オーストラリア・スイスにおける販売承認申請の提出について

2021年04月23日 13:00:00
テクノロジー
JCN Newswire
コメント

TOKYO, Apr 23, 2021 - (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）は、アルツハイマー病治療薬候補であるアデュカヌマブについて、バイオジェン（Nasdaq: BIIB）が4月22日（米国東部時間）に発出した2021年第1四半期決算プレスリリースにおいて、既に発表している米国、欧州、日本以外の国々における販売承認申請の状況を公表しましたのでお知らせします。

バイオジェンは、2021年第1四半期にブラジル国家衛生監督庁にアデュカヌマブの販売承認申請を提出し、現在審査に向けた作業が進んでいます。

また、バイオジェンは、カナダ保健省、オーストラリア医療製品管理局、スイス医薬品局にもそれぞれアデュカヌマブの販売承認申請を提出しました。これらの販売承認申請は、現在、各当局により承認審査に向けた申請受理の可否に関するバリデーションが行われています。

当社は、アデュカヌマブについて、バイオジェンと共同開発しています。

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/2021/news202129.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。

Copyright 2021 JCN Newswire. All rights reserved. www.jcnnewswire.com

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