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Anti-flu Avigan® meets the primary assessment criterion in phase III of clinical trial in Japan for patients with COVID-19

The President of the “FUJIFILM ToyamaChemical” has announced that the primary assessment criterion has been met in the third phase test of “Avigan Tablet” (Generic name: Favpiradiravir, “Avigan”) performed in Japan for patients with new coronavirus infections. The main criterion for efficacy evaluation is the negative conversion time of the SARS-CoV 2 detectable viral RNA in RT-PCR trials and symptom relief (body temperature, oxygen saturation, and images of the thorax). 

FUJIFILM Toyama Chemical started phase III of the Avigan clinical trial in March 2020 in Japan, for patients with non-serious pneumonia. The company carried out a random, placebo-controlled comparative study to evaluate Avigan's effectiveness and safety.  

The average value of the primary rating criteria, using 156 individuals as analysis targets, was 11.9 days for the Avigan group and 14.7 days for the placebo group. FUJIFILM Toyama Chemical confirmed, with a statistically significant difference (value p = 0.0136), that the administration of PIV patients with non-serious pneumonia shows shorter time for resolution. The adjusted risk index showed 1.593 ( 95% confidence interval of 1024 -2.479). No new safety concerns were observed in this trial. 

FUJIFILM Toyama Chemical will perform a detailed analysis of the data obtained in this trial, and will work to present the Request for Parcal Changes to include the additional indication as early as October. 

Approved for manufacture and sale in Japan as an antiviral drug for influenza, Avigan selectively inhibits the RNA polymerase needed for replication of the influenza virus. Because of this action mechanism, Avigan is expected to have an antiviral effect on the new coronavirus, as they are RNA viruses of the same kind as influenza viruses. 

In order to cater for requests from the Japanese government to increase Avigan's and other countries' supplies, the Fujifilm Group has been working to increase Avigan's production in collaboration with strategic partners. The Fujifilm Group will work to deliver the treatment drug to patients of COVID-19 as soon as possible, and will contribute to ending the spread of COVID-19.