Gilead’s remdesivir gets U.S. FDA approval for hospitalized COVID-19 patients

(Reuters) - The U.S. Food and Drug Administration yesterday 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 in the United States.

Remdesivir, given intravenously, was one of the drugs used to treat U.S. President Donald Trump during his bout with COVID-19.

The FDA’s formal approval comes just hours before the president’s final debate with Democratic rival Joe Biden ahead of the Nov. 3 presidential election.

Remdesivir has been available under an FDA emergency use authorization (EUA) 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 (WHO) last week said its global trial of COVID-19 therapies found that remdesivir did not have a substantial effect on patients’ length of hospital stay or chances of survival. That study has not been reviewed by outside experts.

Gilead has questioned the potential for bias in the WHO study, which was not “blinded,” meaning that patients and their doctors were aware of which treatments were being used.

Remdesivir, which will be sold under the brand name Veklury, costs $3,120 for a five-day treatment course, or $ 2,340 for government purchasers such as the Department of Veterans Affairs. Shares of Gilead rose 4.3% in after hours trading to $63.30.

Remdesivir has become the standard of care for patients hospitalized with severe COVID-19 even though it has not been shown to improve survival.