Washington, May 1 (efe-epa).- The Food and Drug Administration (FDA) granted special permission Friday for the use of the experimental drug remdesivir to treat the Covid-19 coronavirus, which has claimed more than 64,000 lives in the United States.
The antiviral medication developed by Gilead Sciences Inc. was shown in a clinical trial to shorten the time to recovery in some people, according to an FDA document on its decision to grant an Emergency Use Authorization (EUA).
“I’m pleased to announce that Gilead now has an EUA from the FDA for remdesivir. And you know what that is because that’s been the hot thing also in the papers and in the media for the last little while,” President Donald Trump told a press conference at the White House where he was joined by the drug company’s CEO, Dan O’Day.
“We have very promising studies coming out on the vaccines. We have promising studies coming out on therapeutics. And the first one is from Dan and Gilead,” Trump said before yielding the podium to O’Day, who said his company planned to donate 1 million doses of remdesivir for Covid-19 treatment.
The president said earlier this week that he would like to see the FDA to act “as quickly as they can” to approve remdesivir.
“We would like to see very quick approvals, especially with things that work,” he said during a meeting at the White House with business leaders.
“There is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with Covid-19,” the FDA said in a statement.
But in the absence of any FDA-approved medicines to treat people hospitalized with, “the FDA has authorized the emergency use of remdesivir for the treatment of Covid-19.”
In a clinical trial overseen by the National Institutes of Health, patients treated with remdesivir recovered 31 percent more rapidly than those who received a placebo.
Gilead said that it would prioritize hard-hit areas in the distribution of remdesivir.
New York state accounts for more than a third of US coronavirus fatalities and for 313,000 of the nation’s 1 million-plus confirmed cases. EFE