Avigan (favipiravir) Meets Endpoints in Phase 3 Japanese Clinical Trial: Sponsor will Register as a Therapy for COVID-19

Sep 25, 2020 | Avigan, COVID-19, Favipiravir, News, Positive Results

Avigan (favipiravir) Meets Endpoints in Phase 3 Japanese Clinical Trial Sponsor will Register as a Therapy for COVID-19

FUJIFILM Toyama Chemical Co., Ltd (FUJIFILM) reports that the primary endpoint has been met for its Phase 3 clinical trial of “Avigan Tablet” (generic name: favipiravir, “Avigan”), conducted in Japan for patients infected with SARS-CoV-2, the virus behind COVID-19. The efficacy primary endpoint is time to negative conversion of detectable SARS-CoV-2 viral RNA in the RT-PCR assays, and time to alleviation of symptoms (body temperature, oxygen saturation and chest images). TrialSite recently reported FUJIFILM would move to commercialize it as a COVID-19 therapy.

Background

FUJIFILM initiated a Phase 3 clinical trial of Avigan in Japan in March 2020, for COVID-19 patients with non-severe pneumonia. The company conducted a randomized, placebo-controlled, single-blind comparative study to evaluate the efficacy and safety of Avigan.

Results

The medium value of primary endpoints, using 156 individuals as analysis targets, were 11.9 days for the Avigan group and 14.7 days for the placebo group. FUJIFILM confirmed, with a statistically significant difference (p value = 0.0136), that the administration of Avigan to COVID-19 patients with non-serious pneumonia demonstrates shorter time to resolution. The adjusted hazard ratio showed 1.593 (95% confidence interval of 1.024-2.479). No new safety concerns were observed in this trial.

File for Registration

FUJIFILM will include more detailed analysis of the data generated from the trial and will thereafter work to file an Application for Partial Changes to include the additional indication as early as October. Avigan is already approved for influenza in Japan (since 2014). More than likely, as TrialSite reported, the favipiravir-based drug will be approved for the COVID-19 indication by the end of the year.

Mechanism of Action

FUJIFILM is already approved for treating influenza. The antiviral selectively inhibits RNA polymerase necessary for influenza virus replication. FUJIFILM’s suggests that this mechanism of action applies to the novel coronavirus as well—which happens to be an RNA virus of the same type as influenza viruses.

Boost in Production

The Japanese government has requested Avigan for its COVID-19 stock pile, hence FUJIFILM has embarked on a path, in collaboration with strategic partners, to produce more of the drug.

Summary of Favipiravir & COVID-19

As TrialSite has chronicled, favipiravir has already been approved in Russia, India, China and Bangladesh as well as other nations as an antiviral therapy for the COVID-19 indication. A handful of clinical trials are now ongoing in the United States.

About  FUJIFILM Toyama Chemical Co., Ltd

FUJIFILM is a Japanese multinational conglomerate including imaging, printing, medical equipment, chemical and biotechnology.  \Based in Tokyo, the conglomerate employs over 30,000.

Source: Fujifilm

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