Flu Antiviral Enters Phase 3 Study in Japan

A late-stage phase 3 clinical trial to evaluate the safety and efficacy of influenza antiviral drug “Avigan Tablet” (favipiravir) in Japan for patients diagnosed with COVID-19 disease, a new respiratory infection has been initiated.

This disease is caused by the novel coronavirus SARS-CoV-2, initially identified in China.

On March 31, 2020, FUJIFILM Toyama Chemical Co., Ltd., issued a press release saying ‘Avigan, approved for manufacture and sale as an influenza antiviral drug in Japan, has a mechanism of action for selectively inhibiting RNA polymerase involved in influenza viral replication.’ 

‘Due to this mechanism, it is expected that Avigan may potentially have an antiviral effect on the new coronavirus, as it is classified into the same type of single-stranded RNA virus like influenza, and its clinical application to treat COVID-19 is now under study.’

Avigan Tablet was approved for manufacture and sale in Japan in 2014 as an influenza antiviral drug.

In early March 2020, Fujifilm began the increased production of Avigan and now plan to accelerate the production of Avigan through cooperation with domestic and overseas partners for responding to the needs of the Japanese government and other countries.

Fujifilm intends to sincerely cooperate with the supply of Avigan to such countries in consultation and coordination with the Japanese government to combat COVID-19 and contribute to tackling the spread of this global pandemic at the earliest possible stage.

This antiviral is to be considered for use only when there is an outbreak of novel or re-emerging influenza virus infections in which other influenza antiviral drugs are either not effective or insufficiently effective, and the Japanese government decides to use the drug as a countermeasure against such influenza viruses. 

The medication is to be supplied only at the discretion of Japan’s Health, Labor and Welfare Ministry. 

It is therefore only manufactured and distributed upon request by the Japanese Government. 

As such, while the Japanese government has a certain stockpile of the drug, Avigan has never been distributed in the market and is not available at hospitals and pharmacies in Japan or overseas.

Recently, China's health leadership announced on March 19, 2020, that they have found the generic, Favipiravir, effective in treating COVID-19 disease in adult patients.

FUJIFILM Toyama Chemical Co., Ltd. conducts the research, development, manufacture, and sales of radiopharmaceuticals and small molecule pharmaceutical products. 

COVID-19 disease treatments published by Precision Vaccinations.