Photo/Illutration Japan has approved remdesivir as a treatment for COVID-19. (Provided by Gilead Sciences Inc.)

Japan swiftly approved the use of the drug remdesivir for COVID-19 patients despite lingering questions about possible side effects and whether the pharmaceutical actually works against novel coronavirus infections.

The health ministry on May 7 approved remdesivir as the first treatment for COVID-19 in Japan, three days after the Japanese subsidiary of U.S.-based Gilead Sciences Inc. submitted the application.

The process was accelerated under a special exception clause for pharmaceuticals that are approved by another nation with comparable standards as Japan’s.

The U.S. Food and Drug Administration on May 1 approved the use of remdesivir as an emergency measure for hospitalized patients with severe symptoms.

The speedy process shows how desperate the Japanese government is about finding any drug that can work against the novel coronavirus in the ongoing pandemic.

But with many uncertainties remaining about remdesivir, which was originally developed to treat Ebola virus infections, its use in Japan will likely be quite limited at first.

The drug will be administered only to patients with severe symptoms of COVID-19 who are on ventilators or extracorporeal membrane oxygenation (ECMO) devices, which circulate blood through an artificial lung.

Gilead Sciences officials said the company has a global supply of about 1.5 million doses, but it is unknown how much will be provided to Japan.

The health ministry will initially manage the supply and distribute remdesivir to hospitals with patients with severe symptoms. The drug will be provided for free at first.

But Japanese doctors do not know how effective remdesivir is against COVID-19 nor whether the drug produces side effects. There is also the danger that remdesivir use could lead to drug-resistant mutations of the virus.

A study of 1,063 individuals carried out by the U.S. National Institutes of Health found that remdesivir led to improved conditions in COVID-19 patients at a quicker pace than among a control group given a placebo.

However, a study by a Chinese group found no statistically significant difference in both the fatality rate and the pace of recovery.

Although the National Center for Global Health and Medicine has been involved in an international study on remdesivir, the drug has been used in only a few clinical trials on patients in Japan.

The lack of sufficient data makes it unclear what type of patients should be given the drug and for how long.

Shinichiro Ueda, a professor of clinical pharmacology at the University of the Ryukyus, believes the government was too hasty in approving remdesivir.

“There has yet to be an assessment about side effects, so patients may be harmed from use of the drug,” he said. “Japan should have only approved the drug after conducting its own clinical tests to confirm its effectiveness and safety.”

The government is also pushing ahead with the approval of Avigan, an anti-flu medicine developed by a Japanese company, for use in treating COVID-19.

(This article was compiled from reports by Shuichi Doi, Hisatoshi Kabata and Hisashi Hattori.)

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