Fujifilm: Avigan Approval Application: Japan Ministry of Health, Labor and Welfare
FUJIFILM Toyama Chemical (Tokyo)
Approval application to the Ministry of Health, Labor and Welfare:
FUJIFILM Toyama Chemical: Avigan
On October 16th, it announced that it had applied to the Ministry of Health, Labor and Welfare to approve the new influenza drug “Avigan” (favipiravir) as a drug for the treatment of new coronavirus infection.
Minister of Health, Labor and Welfare:
At a press conference after the Cabinet meeting on October 6, about the new corona therapeutic drug candidate Avigan
Minister Tamura decides “whether to approve after confirming the effectiveness and safety”.
JIJI dot com
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