The drug is now approved for use in COVID-19 hospital patients aged 12 and older and weighing at least 88 pounds (40 kilograms), according to a FDA statement. Previously, the agency allowed doctors to give remdesivir to hospitalized patients through emergency use authorization or temporary authorization given only “when there are no adequate alternatives,” approved and available “, according to the agency.Now, based on data from three clinical trials, the FDA has decided to fully approve remdesivir. The approval is “supported by data from multiple clinical trials that the agency has rigorously evaluated and represents a scientific milestone in the COVID-19 pandemic,” said FDA Commissioner Dr. Stephen Hahn. Hospitalized patients weighing between approximately 8 pounds and 88 pounds (3.5 to 40 kilograms) or who are under 12 years of age can still receive remdesivir under emergency authorization, at the discretion of their doctor; clinical trials for this group are still ongoing, the FDA noted.Related: 20 of the worst epidemics and pandemics in history
However, despite being the first COVID-19 drug approved by the FDA in the United States, remdesivir is not a very effective treatment, said Dr. Megan Ranney, associate professor of emergency medicine and health. public at Brown University in Rhode Island. BuzzFeed News.
“This is absolutely not a blockbuster drug or a wonder drug,” Ranney told BuzzFeed. “We are giving it to COVID hospital patients because we have nothing better, which is frustrating. ”
“It’s not a blockbuster drug,” said Dr. Peter Lurie, former associate commissioner of the FDA and now president of the Center for Science in the Public Interest, in an interview with Le New York Times. “This is not a major step forward. It is a drug that appears to convincingly benefit patients, but it is not some sort of miracle cure. ”
In trials reviewed by the FDA, remdesivir reduced patients ‘symptoms faster than standard care alone and significantly shortened patients’ hospital stays, the statement said. In a trial that included more than 1,000 patients, those who received the drug spent about five days less in the hospital than those who did not, Previously reported Live Science.
That said, a recent trial conducted by the World Health Organization contradicts these positive results, Previously reported Live Science. The trial, which included more than 11,200 people from 30 countries, found that remdesivir did not significantly reduce patient hospitalization time, nor reduce the risk of being placed on a ventilator. Importantly, the drug did not increase patients’ chances of survival, according to the trial results.
But the WHO trial has yet to be peer reviewed and has drawn criticism from researchers since it went online.
The WHO trial took place in 405 different hospitals around the world, and patient care may have differed from place to place, Dr Peter Chin-Hong, infectious disease specialist at the University of California at San Francisco, told the Times. Differences in care could potentially affect patient survival and make the effects of remdesivir difficult to disentangle. Also, some of the trial participants were sicker than others in the groups, making it difficult to tell whether the drug worked better in one group compared to another, BuzzFeed reported.
Additionally, Gilead Sciences, the company that produces remdesivir, argued that the WHO study could be somewhat biased because doctors and patients knew which drugs were being used, Reuters reported. In other words, the trial was not “blind”, which would be considered the gold standard of a clinical trial.
Whether it helps or not, remdesivir comes at a high price compared to the cheaper treatments tested for COVID-19, such as the steroid dexamethasone. A five-day course of remdesivir costs $ 3,120, or $ 2,340 for government buyers like the Department of Veterans Affairs, Reuters reported. Dexamethasone, on the other hand, costs less than $ 1 a day to treat a single patient, according to the Times. Additionally, as demand for the drug increases worldwide, the global supply of remdesivir has fallen short, BuzzFeed reported.
Originally designed to treat Ebola and hepatitis C, remdesivir works by mimicking a nucleotide, one of the basic molecular building blocks that come together to build viral genes, Live Science reported. This molecular mimicry can infiltrate the genetic material of the coronavirus and prevent it from infecting cells. Most patients tolerate the treatment well, which means unwanted side effects are quite rare, Ranney told BuzzFeed.
Originally posted on Live Science.