OCT 23, 2020 8:30 AM PDT

FDA Gives Full Approval to Remdesivir to Treat COVID-19

WRITTEN BY: Annie Lennon

The US Food and Drug Administration (FDA) has approved antiviral drug Remdesivir, sold under the name ‘Velkury’, for use in adults and children aged 12 and above to treat COVID-19 infections requiring hospitalization. 

Previously, on May 1, 2020, Remdesivir had been given Emergency Use Authorization (EUA) by the FDA, making it available for the entire population while studies on its overall effectiveness were ongoing. As clinical trials assessing the drug’s safety in children are still underway, the FDA has revised the EUA for the drug to continue being used for hospitalized patients with suspected of lab-confirmed COVID-19 who are under the age of 12 and weigh at least 3.5 kg. 

The drug approval comes after the publication of a recent non-peer-reviewed preprint study by the World Health Organization (WHO) showing that Remdesivir, and three other drugs commonly used to treat COVID-19, had marginal effects on the mortality rate for COVID-19 patients. Causing some to doubt the effectiveness of the drug, Gilead Sciences, the pharmaceuritical company behind Remdesivir, warned that the results from the trials have yet to undergo the review process and thus should not be taken without a pinch of salt. 

Nevertheless, other studies have shown that usage of the drug does have some therapeutic effect. A recent study involving 1,062 volunteers, for example, showed that Remdesivir reduces average recovery times (defined as being discharged from hospital or no longer requiring supplemental oxygen or ongoing medical care) from 15 to 10 days. These results reflect early clinical trial results from both the US and China on the drug’s ability to treat COVID-19. 

Considering all available data, it seems that although Remdesivir has almost no effect on death rates, it has shown to be moderately effective in accelerating recovery times for COVID-19. As such, while it is no ‘cure’, it may nevertheless benefit patients recovering from the virus. 

 

Sources: DWFDAThe New York Times

About the Author
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Annie Lennon is a writer whose work also appears in Medical News Today, Psych Central, Psychology Today, and other outlets. When she's not writing, she is COO of Xeurix, an HR startup that assesses jobfit from gamified workplace simulations.
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