As U.S. cases spike back up, hospitals are once again overwhelmed, but this time it’s happening in smaller cities. France has expanded its curfews to cover two-thirds of the population.
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 FDA 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 FDA. 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 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 authorization in May.
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 Center for Science in the Public Interest, said that was not unusual.
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 into new viral genes.
The FDA approval Thursday did not apply to 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 kg and 40 kg or hospitalized pediatric patients less than 12 years of age who weigh at least 3.5 kg. Clinical trials assessing the safety and efficacy of the drug in this pediatric patient population are still continuing, the F.D.A. said.
–Source: The New York Times