The US Food and Drug Administration (FDA) issued Friday an Emergency Use Authorization for remdesivir to treat coronavirus patients after a trial showed promising results.
The decision to green light the Gilead-manufactured drug has the backing of Health and Human Services Secretary Alex Azar, the FDA said in a fact sheet for patients.
“THE PRODUCT MEETS CERTAIN CRITERIA FOR SAFETY”
While the FDA noted the drug has yet to receive a thorough vetting, it said the decision to approve it on an emergency basis was made based “on the totality of scientific evidence available showing that it is reasonable to believe that the product meets certain criteria for safety, performance, and labeling and may be effective in treatment of patients during the coronavirus pandemic.”
The authorization will be in effect for the duration of the coronavirus pandemic unless it is otherwise revoked, according to the FDA.
Addressing reporters at the White House, US President Donald Trump said the drug is offering “really a very promising situation” during the pandemic in which over one million Americans have contracted the virus.
Dr. Anthony Fauci, the US senior-most expert on infectious diseases, earlier this week pointed to results from an international trial of remdesivir, which he said showed the drug “has a clear-cut, significant, positive effect in diminishing the time to recovery” for virus patients.
“If you look at the time to recovery being shorter in the remdesivir arm, it was 11 days, compared to 15 days,” he said at the White House. “What it has proven is that a drug can block this virus.”
The US remains the nation hardest-hit by the coronavirus pandemic with nearly 1.1 million confirmed cases and 64,203 deaths, according to data from Johns Hopkins University in Baltimore, Maryland.