Japan’s Antiviral Flu Drug Found Effective Against COVID-19 Infection
A Japan-based medication producer announced that the primary endpoint of a limited phase III clinical trial of “Avigan Tablet” was met.
FUJIFILM Toyama Chemical Co., Ltd. confirmed in a press release, with a statistically significant difference (0.0136), that the administration of Avigan to COVID-19 patients, with non-serious pneumonia, demonstrates a shorter time to resolution.
FUJIFILM stated on September 23, 2020, the efficacy primary endpoint was time to negative conversion of detectable SARS-CoV 2 viral RNA in the RT-PCR assays and to the alleviation of symptoms, such as body temperature, oxygen saturation, and chest images.
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.
The adjusted hazard ratio showed 1.593 (95% confidence interval of 1.024 – 2.479). And, no new safety concerns were noted in this trial, which began in March 2020.
FUJIFILM stated it ‘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 2020.’
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.
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 the production of Avigan in collaboration with strategic partners.
Avigan is sold under various brands around the world, such as FabiFlu, Avifavir, Ciplenza, FluGuard, Avifavir, and Coronavir.
The Fujifilm Group added: ‘it will work to deliver the treatment drug to COVID-19 patients as soon as possible, and contribute to ending the spread of COVID-19.’
Avigan undergoes an intracellular phosphoribosylation to be an active form, favipiravir-RTP (favipiravir ribofuranosyl-5′-triphosphate), which is recognized as a substrate by RdRp, and inhibits the RNA polymerase activity. Since the catalytic domain of RdRp is conserved among various types of RNA viruses, this mechanism of action underpins a broader spectrum of anti-viral activities of favipiravir.
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