Japan plans to authorize the use of remdesivir, the antiviral drug to treat COVID-19 patients with an eye to approving another drug Avigan this month. This would make Japan the second country to approve the drug after US regulators authorized it for emergency use against severely ill coronavirus patients. Government spokesperson, Yoshihide Suga at the regulatory panel of the health ministry said if there is no problem authorities are hoping to swiftly approve the drug.
Prime Minister Shinzo Abe said the government was getting ready to give a speedy green light to the experimental antiviral drug developed by U.S pharmaceutical company, Gilead Sciences. The U.S approval came after the major clinical trial showed that remdesivir which was basically developed to treat Ebola, shortened the recovery time in some coronavirus patients. The difference in the death rate was not statistically significant.
Finding an effective treatment for COVID-19, the respiratory illness caused by the novel coronavirus, can move the world closer to ease restriction measures and lockdown put in place to control the spread of this highly-contagious virus. The early analysis showed that about two-thirds of severely ill patients improved when treated with this antiviral drug.
Multiple clinical trials of this antiviral drug are still under process. The World Health Organization (WHO) prematurely published findings of a Chinese trial by accident but retracted it soon after. The WHO post indicated that the remdesivir didn’t show benefits in reducing virus load and preventing deaths, but the trial was halted early as researchers struggled to enrol the infected patients.
Remdesivir was already available to some patients who participated in clinical trials around the globe. Remdesivir gets incorporated into the genome of the virus, short-circuiting the replication process. As for Avigan which is developed by Fujifilm Toyama Chemical, the Japanese firm, Suga said the government plans to approve this drug this month if its clinical trial proves effective.
The drug, with the generic name favipiravir, was approved for treatment in 2014 in Japan but only in those flu outbreaks that are not being effectively treated by existing drugs. It can only be manufactured and distributed at the order of the Japanese government. It will not be available in the market.
Favipiravir, which can be taken orally as a pill, it works by blocking the virus ability to replicate inside a cell. In animal studies, Avigan has been shown to affect the development of the fetus, which means it can’t be given to pregnant women.
The plan of Japanese health authorities to approve remdesivir for treating coronavirus infected patients is to accelerate the process. Japan is piggybacking on the U.S. authorization of this antiviral drug. Remdesivir, developed by an American firm will be given to severely patients. It is the first drug that is approved by Japan’s health ministry to treat the novel coronavirus virus.
Last week, remdesivir was approved as an emergency drug and granted authorization by the U.S. Food and Drug Administration (FDA). Approval was given under an expedited review process for pharmaceuticals that are sold overseas. Trial outcomes announced by the U.S. National Institutes of Health showed that COVID-19 patients treated with remdesivir recovered in 11 days on average as compared to those given a placebo, recovered in 15 days. The trial found no significant difference in death rates.
Japan’s health ministry plans to approve Avigan this month for treating mild cases of the novel coronavirus, expanding the medical arsenal of the country in hopes of promoting a quicker return to the economy. In a message to local governments, Japan’s Health Ministry said that even if the drug is approved, its supplies may be limited and will be strictly controlled by the government.