The Food and Drug Administration said Thursday that it had formally approved remdesivir as the first drug to treat Covid-19, a move that indicated the government’s confidence in its safe and effective use for hospitalized patients.
The F.D.A. said the antiviral drug had been approved for adults and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) who require hospitalization for Covid-19, the disease caused by the coronavirus, which has killed more than 220,000 people in the United States.
In May, the F.D.A. granted remdesivir emergency authorization after a trial by the National Institutes of Health found that it modestly reduced the time to recovery in hospitalized patients. President Trump received the drug after he began showing symptoms earlier this month.
The drug does not prevent deaths in Covid-19 patients.
The formal approval now granted by the F.D.A. indicates that the drug cleared more rigorous regulatory hurdles involving a more thorough review of clinical data and manufacturing quality since it was given emergency authorization in May.
“The FDA is committed to expediting the development and availability of Covid-19 treatments during this unprecedented public health emergency,” Stephen M. Hahn, the F.D.A. commissioner, said in a statement. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic.”
The drug was approved less than two weeks before Election Day, amid a campaign overshadowed by the pandemic. Mr. Trump, widely criticized over his administration’s handling of the crisis, has repeatedly promised a “cure” as the virus spreads to all corners of the country, and skeptics have expressed concerns about the politicization of health agencies.
Before its approval, remdesivir did not go through an outside panel of experts, called an advisory committee. But Dr. Peter Lurie, a former associate commissioner with the F.D.A. who is now president of the Center for Science in the Public Interest, said that was not unusual.
“The F.D.A. tends to pick for advisory committees those drugs that are most novel and those that present safety issues, and those that are close calls with respect to effectiveness,” Dr. Lurie said. “This is not a blockbuster drug. This is not some massive breakthrough. It’s a drug that appears convincingly to benefit patients, but it’s not some kind of miracle cure.”
A study of more than 11,000 people in 30 countries sponsored by the World Health Organization found that the drug failed to prevent deaths in patients with Covid-19.
Remdesivir, which was originally developed as a treatment for Ebola and hepatitis C, interferes with the reproduction of viruses by jamming itself…