Gilead’s remdesivir gets US FDA approval for use in hospitalized COVID-19 patients

An ampule of Gilead Sciences COVID-19 antiviral remdesivir is pictured during a news conference at the University Hospital Eppendorf (UKE) in Hamburg, Germany, April 8, 2020, as the spread of coronavirus disease (COVID-19) continues. Ulrich Perrey/Pool via REUTERS

The U.S. Food and Drug Administration on Thursday approved Gilead Sciences Inc’s antiviral drug remdesivir for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease.

Gilead said it is currently meeting real-time demand for remdesivir, which is sold under the brand name Veklury, in the United States and anticipates meeting global demand by the end of October.

Remdesivir, previously granted emergency use authorization by the FDA for COVID-19, was one of the drugs used to treat U.S. President Donald Trump’s coronavirus infection.

Remdesivir has become the standard of care for patients hospitalized with severe COVID-19 after a major study led by the National Institutes of Health showed that it reduced hospital stays by five days.

But doctors have remained wary of using the drug in patients with less severe illness.

The World Health Organization last week said its international trial of COVID-19 therapies found that remdesivir did not have a substantial effect on patients’ length of hospital stay or chances of survival. The study has not been reviewed by outside experts.

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