富士胶片：Avigan的批准申请：日本厚生劳动省
富士富山化学（东京）
申请厚生劳动省批准：
富士富山化学：Avigan
10月16日，它宣布已向厚生劳动省提出申请，批准将新型流感药物“ Avigan”（Fabipyravir）用作新型冠状病毒感染的药物。
厚生劳动大臣：
在10月6日内阁会议后的新闻发布会上，关于新的电晕候选药物阿维根（Avigan）
田村部长决定“在确认有效性和安全性后是否批准”。
时事网
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