Remsdesvir: Some experts troubled about FDA approval for COVID-19 treatment

The United States reached a milestone, of sorts, when last week the Food and Drug Administration approved the first treatment for Covid-19.

The drug is called Veklury, although most people know it by its scientific name, remdesivir.

On Wednesday, its manufacturer, Gilead Sciences, said that remdesivir, which has been authorized for emergency use since the spring, had brought in $873 million in revenues so far this year and that it was the company’s second-best-selling drug in the third quarter, behind its H.I.V. drug, Biktarvy.

But the F.D.A.’s decision to grant the drug full approval — which means the company can now begin broadly marketing it to doctors and patients — has puzzled several outside experts, who say that it may not deserve the agency’s stamp of approval because it is, at best, a mediocre treatment for Covid-19, the disease caused by the coronavirus. And they have questioned whether Gilead deserves to pocket potential billions from the drug when the federal government has played a significant role in its development.

“This is a troubling approval,” said Dr. Peter B. Bach, the director of the Center for Health Policy and Outcomes at Memorial Sloan Kettering Cancer Center. “This is an extremely weak set of trials to support an approval for an antiviral.”

Remdesivir was seen as one of the brightest hopes in the dark days of March and April, when doctors had few tools to treat a new disease and families rushed to gain access to the drug in a desperate gambit to save their dying relatives.

More than six months later, enthusiasm has fizzled. One large, government-run trial showed that the drug shortens patients’ recovery times, but the two other studies the F.D.A. used to justify its approval — sponsored by Gilead — did not compare the treatments with a placebo, the gold standard for evaluating a drug. No studies have shown that it significantly lowers death rates. ...

The drug was initially used on the very sick, but has since been found to work better earlier in the course of the disease. It is routinely given as a five-day treatment to people who are hospitalized for Covid-19, including to President Trump when he was infected earlier this month....