Image of the ultrastructural morphology of the novel coronavirus 2019 (2019-nCoV). Image credit: CDC
The maker of the anti-influenza drug Avigan said Wednesday it would apply for the drug to be approved for treating coronavirus patients after studies showed it can shorten recovery time.
In a statement, the manufacturer Fujifilm Toyama Chemical announced that the phase III study started in March in Japan has now been completed.
Out of 156 people named "Analysis Targets", the median recovery time was 11.9 days in those given Avigan compared with 14.7 days in those given placebo.
Recovery was defined in the study to mean that the virus was no longer detectable in PCR tests and symptoms related to temperature, oxygen saturation, and breast imaging were improved.
The "randomized, placebo-controlled, single-blind comparative study" did not raise any new safety concerns, said Fujifilm.
The company said it will now "conduct a detailed analysis of the data received in this study and work to submit a partial amendment request as early as October to include the additional indication."
The drug, the generic name of which is favipiravir, was approved for use in Japan in 2014, but only for outbreaks of flu that existing drugs do not effectively control.
It is not available on the market and can only be manufactured and sold at the request of the Japanese government.
Favipiravir, which can be taken orally as a pill, blocks the ability of a virus to replicate in a cell.
Avigan has been shown in animal studies to affect fetal development, which means it is not given to pregnant women.
Japan has strongly endorsed the drug and asked Fujifilm to ramp up production for home use and make it available for free to dozens of countries that have made inquiries.
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Avigan manufacturer applies for virus treatment approval after studies (2020, September 23)
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