The Meals and Drug Administration mentioned on Thursday that it had formally permitted remdesivir as the primary drug to deal with Covid-19, a transfer that indicated the federal government’s confidence in its protected and efficient use for hospitalized sufferers.
The F.D.A. mentioned the drug had been permitted for adults and pediatric sufferers 12 years of age and older and weighing at the least 40 kilograms (about 88 kilos) who require hospitalization for Covid-19, the illness attributable to the coronavirus, which has killed greater than 220,000 folks in the USA.
The F.D.A. had granted remdesivir emergency authorization in Could after a trial by the Nationwide Institutes of Well being discovered that it modestly diminished the restoration time in hospitalized sufferers. President Trump obtained the antiviral drug after he started displaying signs earlier this month. The drug doesn’t forestall dying from Covid-19.
The formal approval by the F.D.A. indicated that the drug had cleared extra rigorous regulatory hurdles involving a extra thorough evaluation of medical information and manufacturing high quality because it was given emergency authorization in Could.
“The FDA is dedicated to expediting the event and availability of Covid-19 therapies throughout this unprecedented public well being emergency,” Dr. Stephen M. Hahn, the company’s commissioner, mentioned in a press release. “As we speak’s approval is supported by information from a number of medical trials that the company has rigorously assessed and represents an necessary scientific milestone within the Covid-19 pandemic.”
Remdesivir, which was initially developed as a therapy for Ebola and hepatitis C, interferes with the replica of viruses by jamming itself into new viral genes. A research of greater than 11,000 folks in 30 international locations sponsored by the World Well being Group discovered that the drug failed to prevent deaths in patients with Covid-19.
The drug did not go through an outside panel of experts, called an advisory committee, before being approved.
Dr. Peter Lurie, a former associate commissioner with the F.D.A. and 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.”
Thursday’s approval did not cover the entire population that was covered under the agency’s emergency authorization in May.
That emergency authorization allows doctors to use the drug on hospitalized pediatric patients weighing between 3.5 kilograms (not quite 8 pounds) and 40 kilograms or hospitalized pediatric patients less than 12 years of age who weigh at least 3.5 kilograms. Clinical trials assessing the safety and efficacy of the drug in this pediatric patient population are ongoing, the F.D.A. said.
The drug was approved less than two weeks before Election Day, as Mr. Trump has been promising a “cure” for Covid-19. Shares of Gilead Sciences, the company that makes remdesivir, rose on Thursday amid news of the F.D.A. action.
“As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks,” Dr. Hahn said.
Gina Kolata and Sheila Kaplan contributed reporting.