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S. Korea allows marketing authorization of remdesivir

17:10 July 24, 2020

SEOUL, July 24 (Yonhap) -- South Korea has granted marketing authorization to use remdesivir for coronavirus treatment, the country's drug safety agency said Friday.

The drug that is sold as Veklury and made by U.S. pharmaceutical giant Gilead Sciences Inc. contains the antiviral substance that has been shown to help COVID-19 patients, the Ministry of Food and Drug Safety said.

Seoul has already allowed the special import of the drug for emergency use since June, with the latest move expected to make it easier to secure adequate supply of the medicine going forward, it said.

Domestically, the substance that was originally made to combat Ebola has been administered to 76 people at 27 hospitals as of Tuesday.

The ministry said the latest authorization is conditional on Gilead providing Seoul with final data on the most recent clinical tests and sending production and safety control standards it is using for the production of the medicine within a set period of time.

It said Japan, the European Union and Singapore have already all given the same kind of conditional authorization for Veklury based on results of tests conducted so far.

Marketing authorization, unlike special imports, indicates that considerable safety and effectiveness trials have been carried out on a substance, even though some tests results need to be checked and analyzed further.

"The latest move takes into account that Veklury has undergone extensive clinical trials in 10 countries and by 73 medical institutions, with initial reports indicating that it can reduce the hospitalization period of infected people by some 31 percent," the drug safety authority said.

It added that the move could allow South Korea to better respond to a possible spike in COVID-19 cases.

The country identified 41 new COVID-19 cases on Friday, raising the total caseload here to 13,979, with the death toll reaching 298, up one from the previous day.

This file photo shows Gilead's remdesivir stored in vials. (Yonhap)

yonngong@yna.co.kr
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