F.D.A. Approves First Drug for Treating Coronavirus Patients

Giulia McDonnell Nieto del Rio and Nicholas Bogel-Burroughs

As US 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 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 into new viral genes.

The F.D.A. 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.


Shares of Gilead Sciences, the company that makes remdesivir, rose on Thursday amid news of the F.D.A. action.

A hospital in Idaho is 99 percent full, and warning that it may have to transfer coronavirus patients to hospitals as far away as Seattle and Portland, Ore. Medical centers in Kansas City, Mo., have turned away ambulances recently because they had no room for more patients. And just outside Milwaukee, a new emergency field hospital set up on the Wisconsin State Fairgrounds admitted its first virus patient this week.

As the United States neared a bleak record on Thursday, recording the second-highest number ever of new daily coronavirus cases — over 74,000 — more than 40,000 people were being treated in hospitals for infections. That’s a figure that has risen by 40 percent over the last month as new cases have surged, with cooler weather pushing more people indoors.

At least 14 states have had more people hospitalized for the virus on a day in the past week than at any other time since the pandemic began, according to the Covid Tracking Project, and seven more states are nearing their peaks.

“Make no mistake about this, this is an urgent crisis,” Gov. Tony Evers of Wisconsin said at a news conference on Thursday.

As a whole, the nation has had more people hospitalized at earlier points in the pandemic, during surges of cases in New York City in April and in the Sunbelt in July. But the sharply rising numbers now are deeply worrisome, not least because they are testing the limits of more limited hospital systems in smaller places.

Patients are now spread more broadly across the country, with troubling hot spots from North Dakota to Kentucky. And more people than ever are falling critically ill in rural areas, particularly in the Midwest and Mountain West, where they often must rely on hospitals with only a handful of beds.

In Utah, Dr. Angela Dunn, the state epidemiologist, seemed exasperated as she pleaded with people to take precautions. “Our health care system is at capacity, our health care providers are overwhelmed and exhausted, our public health system is stressed,” she said.

“I don’t know what to do anymore,” Dr. Dunn said. “I’m really not trying to scare anyone, I’m just trying to inform you of what’s going on.”

Experts worry that the strains will only grow as cases explode.


“I don’t really see any signs that things are slowing down, and that concerns me a lot,” said Caitlin M. Rivers, an epidemiologist at Johns Hopkins University. “It has to be our starting premise that it’s not going to slow down unless we force it to slow down.”- The New York Times