2020.05.04 16:52Nation

米社がレムデシビル申請 厚労省、新型コロナ治療へ近く承認

 新型コロナウイルス感染症の治療薬候補の抗ウイルス薬「レムデシビル」を開発した米ギリアド・サイエンシズが、厚生労働省に薬事承認に向けた申請を行ったことが4日、分かった。厚労省は、海外での承認などを条件に審査手続きを大幅に短縮できる「特例承認」を適用し、近く承認する見通し。
 レムデシビルは、エボラ出血熱の治療目的でギリアド社が開発。同社の臨床試験(治験)では、新型コロナ感染者に一定の効果があったとされる。(2020/05/04-16:52)

2020.05.04 16:52Nation

Gilead Files for Remdesivir Approval in Japan


Gilead Sciences Inc. has filed for Japanese regulatory approval of its remdesivir, a potential antiviral drug to treat patients with the coronavirus, sources familiar with the matter said Monday.
   The health ministry is expected to approve remdesivir shortly using a fast-track process that allows for substantially shortened screening procedures on condition that the drug being examined has been approved overseas.
   The U.S. pharmaceutical firm developed remdesivir as an Ebola therapy. The drug showed certain benefits in coronavirus patients in Gilead's clinical trials, according to the company.
   On Saturday, health minister Katsunobu Kato said, "I've instructed officials to be prepared to be able to grant approval in about a week once the application is made."

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