Japanese health authorities were unable to reach a decision on the efficacy of the antiviral drug Avigan in the treatment of COVID-19 patients based on the results of clinical trials by its therapist, government sources said Wednesday.
The latest evaluation by the Agency for Pharmaceuticals and Medical Equipment will be a key topic for a health ministry review panel that is likely to decide Monday whether to allow Avigan’s use to treat COVID-19 in Japan .
Drugmaker Fujifilm Toyama Chemical Co., a unit of Fujifilm Holdings Corp., filed an application to use the drug to combat COVID-19 in October. Avigan has already been licensed for use with flu cases.
Some medical experts have opposed the use of Avigan, also known as favipiravir, for the treatment of patients with COVID-19.
Possible side effects of liver function are getting worse, but Fujifilm said new safety concerns have not been identified. Pregnant women cannot use the drug because some animal studies have shown that it is possible for fetal anomalies.
There are growing expectations that Avigan would become the third treatment drug for COVID-19 in Japan, following the antiviral drug remdesivir developed by US company Gilead Sciences Inc. and the steroid dexamethasone.
The evaluation acknowledged that allowing the use of Avigan as a COVID-19 drug would be “meaningful” at a time when there are few treatment options available.
Japan has been battling a resurgence of coronavirus outbreaks in the past few weeks, forcing Prime Minister Yoshihide Suga to suspend a subsidy program to encourage domestic travel, as a result of the stand earlier.
According to data collected during a clinical trial on 156 patients without severe COVID-19 symptoms, Fujifilm found that those administered by Avigan showed improvement after 11.9 days, shorter than 14.7 days for those in it. the placebo group.
One of the issues raised in the assessment report is the way in which the tests were carried out. The doctors knew which patients received Avigan or a placebo, which the report argues prevented them from properly assessing symptoms, the sources said.
Government sources also said the criteria for determining whether symptoms had improved were not clear, based on body temperature and other data.
Fujifilm initially took longer than expected to complete its clinical study that began in March after struggling to get enough patients due to the low incidence of coronavirus cases in Japan.
While in office, Prime Minister Shinzo Abe had expressed hope that the drug would be adopted in May and the government decided to collect enough of the drug to treat 2 million people.
Fujifilm aims to market Avigan for COVID-19 treatment overseas, including in China.
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