The drug is called Veklury, although most people know it by its scientific name, remdesivir.
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 HIV drug, Biktarvy. But the FDA’s decision to grant the drug full approval — which means the company can 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, 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 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 FDA 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. And just days before the FDA granted approval, a large study sponsored by the World Health Organization found that remdesivir provided no benefit to hospitalized patients. “I think most people think that because a drug is FDA approved, that means it must work,” said Dr. Aaron S. Kesselheim, a professor of medicine at Harvard Medical School who studies the drug industry. He and other researchers recently found that less than one-third of new drugs approved by the FDA and its European counterpart over the past decade were rated as having a “high therapeutic value” by outside experts. “I think it’s important to recognize that FDA approval doesn’t guarantee a certain level of benefit — all it says is that there is some benefit,” he said. On a call with investors Wednesday, Gilead’s chief executive, Daniel O’Day, said remdesivir had a role to play, along with vaccines and other treatments. “There’s a lot we don’t know about the pandemic, of course, but I think what we do know is that in order to get us all back to normal, this is going to take a variety of approaches,” he said. “We’re proud to be at the front end of this with a very potent antiviral.” Related Articles Surge in virus threatens to reverse global economic rebounds Indiana girl,8, dies after being shot while doing homework Philadelphia pledges better response after Black man’s death At least 1 dead as Hurricane Zeta hammers Gulf Coast Former DHS official says he wrote ‘Anonymous’ Trump critique Remdesivir was originally developed as a treatment for Ebola and hepatitis C and is thought to interfere with the reproduction of viruses by jamming itself into new viral genes.
