Published 10:51 IST, June 3rd 2020
South Korea approves emergency use of remdesivir to treat COVID-19 patients
South Korea’s Ministry for Food and Drug Safety said that it has approved the emergency use of Gilead Sciences Inc’s remdesivir to treat COVID-19 patients.
South Korea’s Ministry for Food and Drug Safety on June 3 reportedly said that it has approved the emergency use of Gilead Sciences Inc’s remdesivir to treat COVID-19. Remdesivir is the first drug to show improvement in COVI-19 patients in formal clinical trials and South Korea approved the use of the drug after a government panel last week cited positive results for the anti-viral drug in other countries.
South Korea’s Ministry for Food and Drug Safety in a reported statement said that remdesivir can help reduce the amount of coronavirus in the body. The ministry believes that the drug can help the patient’s condition improve faster. Gilead also reported that the drug provided a modest benefit in patients with moderate COVID-19 given a five-day course of the treatment, while those who receive the medicine for 10 days in the study did not fare as well.
According to an international media outlet, the South Korean ministry also issued guidelines for the usage of the drug. Under the reported guidelines, doctors can administer one dose of remdesivir a day, with five doses overall for patients with moderate symptoms, and 10 doses for patients with severe symptoms and who need oxygen support. Furthermore, the ministry also said that it will be cooperating with Gilead and other ministries to swiftly import the drug.
Moreover, the South Korean Ministry for Food and Drug Safety also added that all patients must undergo a liver function test before taking the drug as possible side effects include elevated levels of liver enzymes. The country, which was one of the worst-hit, has now been battling a small but steady new outbreak of the deadly virus. Currently, South Korea has more than 11,000 active COVID-19 cases and the disease has claimed nearly 273 lives in the country.
FDA issues Emergency Use Authorisation
Meanwhile, the US Food and Drug Administration (FDA) has also issued an Emergency Use Authorisation for remdesivir for the treatment of COVID-19 due to ongoing health emergency. In the US, the drug is an investigational drug that has not been approved by the FDA for any use, and its safety and efficacy for the treatment of COVID-19 has not been established.
While the company’s CMO said that the study results complement data from a separate trial conducted by the National Institute for Allergy and Infectious Diseases, it didn’t disclose further details about the study. Gilead Sciences Inc. made it clear that remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19.
(Image: AP)
Updated 10:51 IST, June 3rd 2020