The FDA extended its first ever approval (not just an emergency authorization) for a drug to treat COVID-19. The drug is one you’ve probably heard of: the antiviral remdesivir, which has been in use in hospitals for the past few months.
What is remdesivir?
Remdesivir, marketed under the brand name Veklury, is an antiviral. This means it interferes with the process by which the virus makes more of itself inside human cells. It was previously tested against ebola and hepatitis C, but never made it to market. Veklury is made by the pharma company Gilead, which charges $3,120 per course of treatment for insured patients in the U.S.
Remdesivir is one of the treatments that President Trump was reportedly given when he contracted COVID-19, along with the corticosteroid dexamethasone, and an antibody cocktail made by Regeneron.
How well does it work?
That’s a tricky question. In its press release, Gilead points to a study showing remdesivir reduced time to recovery from 15 days to 10 days, which sounds great.
But other studies have shown less benefit, and some experts are skeptical of whether it does anything useful at all. A recent trial conducted by the World Health Organization found that it didn’t save lives or shorten hospital stays. (The same trial also found no significant benefit to hydroxychloroquine.)
The FDA cites three trials, including the one with five days of improvement, in its announcement. Trials to determine how well remdesivir works are still ongoing, even after its approval.
What does the approval mean?
A full approval requires “substantial evidence of effectiveness and a demonstration of safety for the drug’s intended use(s),” according to the FDA, including an evaluation of how the benefits compare to the risks for the population for which it’s approved.
The approval allows the drug to be used in hospitalized patients, and should only be administered in a hospital. It’s approved for adults and for children who are at least 12 years old and at least 40 kilograms (88 pounds).
Remdesivir was previously available under an emergency use authorization, or EUA, which had less stringent requirements. (Hydroxychloroquine was available under an EUA earlier this year, but the EUA was revoked after further trial results showed that it did not seem to be effective.) At first, in May, the EUA for remdesivir was only for critically ill patients. Then, in August, the EUA was expanded to include all hospitalized patients. The EUA was revised again alongside the approval; now, the EUA allows doctors to prescribe it for children who don’t fall into the approved population.