The US Food and Drug Administration said on 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 hospitalised patients.
The FDA said the antiviral drug had been approved for adults and paediatric patients 12 years of age and older and weighing at least 40kg who require hospitalisation for Covid-19, the disease caused by the coronavirus, which has killed more than 220,000 people in the US.
In May, the FDA had granted remdesivir emergency authorisation after a trial by the National Institutes of Health found that it modestly reduced the time to recovery in hospitalised patients. President Donald 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 FDA 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 authorisation 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 FDA commissioner, said in a statement. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed...”
The drug was approved less than two weeks before Election Day, amid a campaign overshadowed by the pandemic. Trump, widely criticised over his administration’s handling of the crisis, has repeatedly promised a “cure” as the virus spreads to all corners of the country, and sceptics have expressed concerns about the politicisation 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 FDA who is now president of the Centre for Science in the Public Interest, said that was not unusual.
Shares of Gilead Sciences, the company that makes remdesivir, rose on Thursday amid news of the FDA action.
New York Times News Service