富士フイルム：アビガンの承認申請：厚生労働省（動画）：
Fujifilm: Avigan Approval Application: Japan Ministry of Health：
富士胶片：Avigan的批准申请：日本厚生劳动省
富士フイルム富山化学（東京）
厚生労働省に承認申請：
10月１６日、新型インフルエンザ治療薬「アビガン」（ファビピラビル）について、新型コロナウイルス感染症の治療薬としても承認するよう厚生労働省に申請したと発表した。
厚生労働相：
10月６日の閣議後記者会見で、新型コロナ治療薬候補アビガンについて、
田村大臣は、「有効性や安全性を確認した上で承認するかどうか」を決める。
時事ドットコム
https://www.jiji.com/jc/article?k=2020101600574&g=eco
Fujifilm Filed an Application for Partial Changes to the Manufacturing and Marketing Approval Matters of Anti-Influenza Drug Avigan® Tablet in Japan to Include Additional Indication for COVID-19
TOKYO, October 16, 2020 —
FUJIFILM Toyama Chemical Co., Ltd.
has announced that the company filed an Application for Partial Changes to manufacturing and marketing approval matters of its anti-influenza drug Avigan® Tablet (generic name: favipiravir,“Avigan”) to the Ministry of Health, Labour and Welfare in Japan.
The filing
seeks to add an indication and other items relating to novel coronavirus infections (hereinafter “COVID-19”).
Avigan,
approved for manufacture and sale in Japan as an influenza antiviral drug,selectively inhibits RNA polymerase necessary for influenza virus replication.
Due to this mechanism of action, it has been expected that Avigan may have an antiviral effect on the novel coronavirus, as they are RNA viruses of the same type as influenza viruses.
FUJIFILM Toyama Chemical
conducted phase III clinical trial in Japan in March of this year for COVID-19 patients with non-severe pneumonia.
The company confirmed,
with a statistically significant difference, that the administration of Avigan demonstrates shorter time to resolution, with no new safety concerns identified.
Based on the results of this trial,FUJIFILM Toyama Chemical
filed an Application for Partial Changes to manufacturing and marketing approval matters of Avigan.
The filing seeks to add, indication as well as dosage and administration concerning COVID-19 to the current manufacturing and marketing approval items of Avigan.
Fujifilm Global
https://www.fujifilm.com/news/n201016_01.html