Korea to discuss approving remdesivir for treating COVID-19

Posted on : 2020-05-26 17:08 KST Modified on : 2020-05-26 17:34 KST
Drug shown to reduce recovery time and mortality rate in US clinical trials
A screening clinic in Seoul’s Gangnam District. (Yonhap News)
A screening clinic in Seoul’s Gangnam District. (Yonhap News)

With large-scale clinical trials demonstrating the limited effectiveness of remdesivir, an Ebola virus treatment developed by US pharmaceutical company Gilead, in treating COVID-19, South Korean disease control authorities announced on May 25 that they planned to hold discussions with the Ministry of Food and Drug Safety (MFDS) on approval and supplies for its emergency use.

Speaking in a regular briefing that afternoon, Korea Centers for Disease Control and Prevention (KCDC) Director Jung Eun-kyeong said, “In clinical trials with remdesivir, it was reported to be capable of reducing recovery time and lowering mortality rates.”

“We are preparing to ask the central clinical committee for its opinion on whether to pursue its emergency use in South Korea, after which we would be making a request with the MFDS,” she explained.

The US National Institutes of Health (NIH) conducted a clinical trial on 1,063 COVID-19 patients in serious and critical condition in cooperation with researchers from 10 countries, including South Korea, and published the results in the New England Journal of Medicine on May 23. The researchers found that patients who were administered remdesivir (the experimental group) had an average recovery time of 11 days, which was four days (31%) shorter than the 15-day average for patients who were administered a placebo (the control group). Furthermore, the mortality rate after 14 days was lower in the experimental group (7.1%) than the control group (11.9%). Fewer patients reported side effects in the experimental group (21.1%) than in the control group (27.0%).

“[The medication] was found to not only improve clinical condition and shorten recovery time but also to reduce the mortality rate, though not to a statistically significant degree. This was a well-designed blind clinical trial with a control group, so we regard [the medication’s] effectiveness and stability as having been verified,” said Jung.

The research team stated in their paper that the study proves that remdesivir has a greater therapeutic effect than a placebo. But they also cautioned that, in light of the high mortality rate, remdesivir should not be administered by itself but should be accompanied by other medications or treatments.

The NIH received emergency use authorization from the US Food and Drug Administration (FDA) on May 8 to administer remdesivir to patients in severe condition who need oxygen therapy. But the NIH recommends that remdesivir not be prescribed to patients with mild symptoms.

By Lee Keun-young, staff reporter

Please direct comments or questions to [english@hani.co.kr]


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