TOKYO: Japan will fast-track a review of Gilead Sciences Inc’s antiviral drug remdesivir so that it can hopefully be approved for domestic COVID-19 patients a week after the US firm’s filing for such approval, the health minister said on Saturday (May 2).
Health Minister Katsunobu Kato’s comment comes after remdesivir was granted emergency use authorisation by the US Food and Drug Administration for COVID-19 on Friday.
“I’ve heard that Gilead Sciences will file for approval (in Japan) within days,” Kato told reporters. “I issued an instruction so that we will be ready to approve it within a week or so.”
Prime Minister Shinzo Abe said on Friday he was leaning towards extending Japan’s state of emergency, due to expire on May 6, for a month as experts said coronavirus restrictions should remain in place until the number of cases falls further.
Japan has confirmed nearly 15,000 cases and 517 deaths from COVID-19, according to an NHK tally.
Tokyo, the capital, saw a decline in daily reported cases since hitting a peak of 201 on Apr 17, with further falls into double digits this week, but the numbers jumped back far above 100 on Friday and Saturday.
The Nikkei business daily has said although Gilead planned to distribute enough doses to cover 140,000 patients worldwide, Japan would not receive enough for all its patients in need.
No one was immediately available for comment at Gilead’s Japanese unit.
Remdesivir, which previously failed as a treatment for Ebola, is being tried against COVID-19 because it is designed to disable the mechanism by which certain viruses, including the coronavirus, make copies of themselves and potentially overwhelm their host’s immune system.