The U.S. Food and Drug Administration on Thursday approved Gilead (NASDAQ:GILD)'s antiviral drug remdesivir for treating patients hospitalized with COVID-19, making it the first and only drug approved for the disease in the United States.
Remdesivir, given intravenously, was one of the drugs used to treat President Donald Trump, who tested positive for the respiratory disease earlier this month.
The FDA's formal approval came just hours before the president's final debate with Democratic rival Joe Biden ahead of the Nov. 3 presidential election.
Trump's seemingly dismissive approach to the coronavirus has clouded his re-election prospects, with polls showing Americans losing confidence in his ability to handle the pandemic.
Remdesivir has been available under an FDA emergency use authorization since May, after a study led by the National Institutes of Health showed it reduced hospital stays by five days.
However, the World Health Organization last week said its global trial of COVID-19 therapies found that the drug did not have a substantial effect on patients' length of hospital stay or chances of survival.
At $3,120 for a five-day treatment course, remdesivir has become the standard of care for patients hospitalized with severe COVID-19 even though it has not been shown to improve survival.
Doctors have remained wary of using it in patients with less severe illness.