SEOUL (Reuters) - South Korea said on Wednesday it has approved the emergency use of Gilead Sciences Inc’s remdesivir to treat COVID-19 after a government panel last week cited positive results for the anti-viral drug in other countries.
Remdesivir, which is administered intravenously in hospital, is the first drug to show improvement in COVID-19 patients in formal clinical trials.
“Remdesivir can help reduce the amount of coronavirus in the body,” South Korea’s Ministry for Food and Drug Safety said in a statement. “This can help the patient’s condition improve faster.”
On Monday, Gilead reported the drug provided a modest benefit in patients with moderate COVID-19 given a five-day course of the treatment, while those who received the medicine for 10 days in the study did not fare as well.
The U.S. Food and Drug Administration granted emergency use authorisation (EUA) last month, citing results from a U.S. government study that showed the drug reduced hospitalisation stays by 31%, or about four days, compared to a placebo. Japanese health authorities have also approved use of the drug.
Under guidelines announced by South Korea’s Ministry for Food and Drug Safety, doctors can administer one dose of remdesivir a day, with 5 doses overall for patients with moderate symptoms, and 10 doses for patients with severe symptoms and who need oxygen support.
The ministry said it will cooperate with Gilead, the Korea Centers for Disease Control and Prevention and other ministries to swiftly import the drug.
All patients must undergo a liver function test before taking the drug as possible side effects include elevated levels of liver enzymes, the ministry added.
South Korea has been battling small but steady new outbreaks of the new coronavirus, with 49 new cases reported on Tuesday, bringing the country’s total to 11,590 cases with 273 deaths.
Reporting by Josh Smith and Sangmi Cha; Additional reporting by Jane Chung; Editing by Edwina Gibbs
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