Fujifilm to Seek Approval for Anti-Influenza Drug to Treat COVID-19 Patients After Positive Phase 3 Trial Results

Fujifilm Toyama Chemical’s (Tokyo, Japan) flu drug Favilavir, which is currently being promoted with the label, Avigan, has met the primary endpoint in Phase 3 clinical trial for patients with novel coronavirus infections, and the company now plans to seek approval for its use as treatment for COVID-19.

Approved for manufacture and sale in Japan as an influenza antiviral drug, Avigan, selectively inhibits RNA polymerase necessary for influenza virus replication. Due to this mechanism of action, it is expected that Avigan may have an antiviral effect on the new coronavirus, as they are RNA viruses of the same type as influenza viruses. Fujifilm Toyama Chemical began a Phase 3 clinical trial of Avigan in Japan in March 2020, for COVID-19 patients with non-severe pneumonia. The company conducted randomized, placebo-controlled, single-blind comparative study to evaluate the efficacy and safety of Avigan.

The median 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 Toyama Chemical 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 noted in this trial. The company will conduct a detailed analysis of the data obtained in this trial, and will work to file Application for Partial Changes to include the additional indication in as early as October.

The Japanese government has already stockpiled Avigan in preparation for the outbreak of the novel influenza. To meet the requests of the Japanese government to increase stockpiles of Avigan, and by other countries to supply the drug, the Fujifilm Group has been working to increase production of Avigan in collaboration with strategic partners. The Fujifilm Group will work to deliver the treatment drug to COVID-19 patients as soon as possible, and contribute to ending the spread of COVID-19.