FDA grants emergency authorization to use drug remdesivir for some coronavirus cases

After a trial showed the drug remdesivir produced by the company Gilead effectively treats coronavirus, the U.S. Food and Drug Administration issued an emergency-use authorization for hospitalized COVID-19 patients, CNN reported.

President Donald Trump made the announcement Friday afternoon alongside Gilead Sciences Inc. CEO Daniel O’Day, according to CNBC. The drug is the first to have a proven benefit in coronavirus patients in a major clinical trial released this week, The Wall Street Journal reported.

Remdesivir is an antiviral drug that has been used to treat Ebola in the past, according to the Journal. It is currently being studied in multiple different trials around the world for the treatment of COVID-19, the Journal reported.

A study out of the University of North Carolina - Chapel Hill showed that the drug reduces recovery time in coronavirus patients, The News and Observer reported. Researchers found remdesivir reduced recovery time in patients by an average of four days, according to The News and Observer.

Dr. Anthony Fauci, a member of the White House coronavirus task force, says the drug had “a clear-cut significant positive effect,”according to the Associated Press.

“This is a game changer for the treatment of patients with COVID-19 and provides hope to many infected,” UNC epidemiologist Ralph Baric said in a statement obtained by The News and Observer. Baric led lab testing of the antiviral drug at the UNC Gillings School of Public Health.

Emergency-use authorizations have a lower regulatory standard to meet than FDA approval, but it’s a sign that the FDA believes it’s headed in the right direction, according to CNN. The authorization indicates that the drug has not undergone the same level of review, but doctors can now use the drug for hospitalized patients, despite the lack of formal approval, CNBC reported.

“We want to thank the collaborators that brought remdesivir to this point and many of our people that have been part of this, in fact, the caregivers,” O’Day told reporters, according to CNBC.

The FDA limited the authorization to adults and children with severe, lab-confirmed cases of COVID-19, CNN reported. O’Day says that the company’s current supply could cover at least 140,000 coronavirus treatments, according to CNN.

Gilead can now work with the federal government to directly ship the drug to hospitals with the greatest need, O’Day told WSJ. The company expects to produce about 1.5 million doses by the end of this month, The Wall Street Journal reported.

Gilead says it would donate supplies to hospitals and doctors before June, but O’Day has not confirmed how much the company might charge for the drug afterward, according to the Journal.

This story was originally published May 1, 2020 at 5:19 PM with the headline "FDA grants emergency authorization to use drug remdesivir for some coronavirus cases."