FUJIFILM Toyama Chemical Co. Submits Application for Avigan (Favipiravir) Approval for COVID-19 to Japan’s Health Authority

FUJIFILM Toyama Chemical Co. Submits Application for Avigan (Favipiravir) Approval for COVID-19 to Japan's Health Authority

Japan’s FUJIFILM Toyama Chemical Co., Ltd announced that the company filed an Application for Partial Changes to manufacturing and marketing approval matters of its anti-influenza drug Avigan® Tablet (Favipiravir) to the Ministry of Health, Labor and Welfare in Japan. The filing seeks to add an indication and other items relating to novel coronavirus infections (COVID-19). This antiviral drug, originating in Japan, has already been approved in Russia and India, at least on an emergency basis, for COVID-19.

TrialSite News has chronicled a good amount of activity associated with Favipiravir. What follows is a brief breakdown of the news, the drug and status elsewhere.

What is Avigan?

Known by the generic name Favipiravir, Avigan is already approved, since 2014, for manufacture and sale in Japan as an influenza antiviral drug as it selectively inhibits RNA polymerase necessary for influenza viral replication.

What’s the basis for pursuing approval for treating COVID-19?

As Avigan selectively inhibits viral replication it has been sought that it may have an antiviral effect on SARS-CoV-2, the virus behind COVID-19; this novel coronavirus is a RNA virus of a similar type to influenza viruses.

Was there a clinical trial in Japan?

Yes. FUJIFILM Toyama Chemical conducted a Phase 3 clinical trial in Japan in March 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 while introducing no new safety concerns, at least identified.

It was on the basis of the results of this clinical trial that the company moved to file and add an indication as well as dosage and administration concerning COVID-19 to the existing manufacturing and marketing approval items of Avigan.

Is it true that the Japanese government stockpiles this drug for the flu?

Yes. And given that the regulatory agency here may approve the drug, the company reports it must be ready for the pending demand by increasing production capacity in collaboration with strategic partners both within and outside of Japan.

Assuming regulatory approval, when will the drug be ready for patients?

As soon as possible.

What other nations have approved, at least on an emergency basis for COVID-19?

Russia approved its version of the drug called Avifavir as reported by TrialSite June 1. 2020. 

On July 24, TrialSite reported that Favipiravir was authorized by the Indian government during the pandemic. A number of generic pharmaceutical companies have developed brands.

What about in the U.S.?

A number of clinical trials are ongoing, including at least one sponsored by FUJIFILM. But there isn’t much news about this drug in the press.

TrialSite has shared that the U.S. DoD spent over $200m on this drug just five years ago: why?

The DoD studied this antiviral drug, spending over $200 million on sizeable clinical trials. For example, by 2015, collaborative sponsors MDVI, LLC and MediVector, Inc. conducted trials aimed to “help bolster the protection of the Joint Forces against naturally occurring pandemic influenza and/or biologically engineered flu viruses.” 

What happened to the results of these federally-funded clinical trials?

Nothing. No study results were posted on Clinicaltrials.gov; there was no FDA approval and this fact did trigger some questions among select investigative journalists such as those associated with AJPHE