The Food and Drug Administration on Friday approved the emergency use of Remdesivir, an experimental drug that is being tested in treating patients with coronavirus.
A federal trial that showed that treatment with the anti-viral drug could speed recovery in patients infected with COVID-19. President Trump made the announcement from the White House with the drugmaker Gilead Sciences’ CEO Dan O’Day.
Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, had announced the positive news about the drug on Wednesday.
An emergency authorization by the FDA is not the same thing as a formal drug approval by the agency.
When the federal government declares a public health emergency, the FDA can approve drugs or tests to address the emergency if there are no other alternatives.
Fauci said the data showed that Remdesivir had a significant, positive effect in speeding recovery time.
Trump and Fauci hailed the early results of the federal trial, the same day the US death toll passed 60,000.
“It is a very important proof of concept, because what it has proved is that a drug can block this virus,” Fauci said. “This is very optimistic.”
The New York Times reported that the trial enrolled 1,063 patients who were given Remdesivir or a placebo. The time to recovery averaged 11 days among those who got the drug, compared with 15 days for those who got the placebo.