FDA authorizes remdesivir for emergency use against coronavirus pandemic

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FDA authorizes remdesivir for emergency use against coronavirus pandemic
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A government-sponsored study showed the drug shortens patients' recovery times by 31 percent or an average of about four days.

On Friday, Food and Drug Administration Commissioner Stephen Hahn said remdesivir, a broad-spectrum antiviral medication developed by the pharmaceutical company Gilead, is now authorized for emergency use on hospitalized patients with coronavirus.

The FDA head authorized the drug for widespread use after a government-sponsored study showed the drug shortens patients' recovery times by 31 percent or an average of about four days, according to the Associated Press. Gilead announced on March 25, 2020 that it has submitted a request to the Food and Drug Administration to rescind the exclusive marketing rights it had secured for remdesivir, an antiviral drug that shows promise in treating Covid-19, the disease caused by the new coronavirus.Because of the public health emergency created by the coronavirus epidemic, the FDA waived its usual requirements of large group testing and"substantial evidence" before authorizing the drug's widespread use.

"Multiple concurrent studies are helping inform whether remdesivir is a safe and effective treatment for Covid-19 and how to best utilize the drug," said Merdad Parsey, MD, PhD, Chief Medical Officer for Gilead Sciences.

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