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Japan Sets To Approve COVID-19 Drug On Thursday

Thompson Nsisongabasi

May 07, 2020

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Japan plans to authorize Thursday the antiviral drug remdesivir to treat coronavirus patients, the government said, with an eye to approving another medication Avigan this month.

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This would make Japan the second country to approve the drug after US regulators authorized it on Friday for emergency use against severe cases of COVID-19.

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"If there is no problem we hope to swiftly approve (the drug) today" at the health ministry's regulatory panel, top government spokesman Yoshihide Suga told reporters.

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Prime Minister Shinzo Abe said last week the government was getting ready to give a speedy green light to the experimental drug developed by US firm Gilead Sciences.

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The US go-ahead came after a major clinical trial showed remdesivir - originally developed to treat Ebola - shortened the time to recovery in some patients by a third.

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The difference in mortality rate was not statistically significant.

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Remdesivir, which is administered by injection, was already available to some patients who enrolled in clinical trials around the world.

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As for Avigan, developed by Japanese firm Fujifilm Toyama Chemical, Suga said the government "aims to approve it this month" if a clinical trial involving 100 patients proves effective.

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The drug, whose generic name is favipiravir, was approved for use in Japan in 2014 but only in flu outbreaks that are not being effectively addressed by existing medications.

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It is not available on the market and can only be manufactured and distributed at the request of the Japanese government.

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Favipiravir, which can be taken orally as a pill, works by blocking the ability of a virus to replicate inside a cell. Remdesivir incorporates itself into the virus's genome, short-circuiting its replication process.

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Avigan has been shown in animal studies to affect fetal development, meaning it is not given to pregnant women.

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— Thompson Nsisongabasi

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