The drug was approved for all hospitalized COVID-19 patients age 12 and over who weigh at least 88 pounds.
"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," said FDA Commissioner Stephen Hahn. "As part of the FDA’s Coronavirus Treatment Acceleration Program, the agency will to continue to help move new medical products to patients as soon as possible, while at the same time determining whether they are effective and if their benefits outweigh their risks.”
Remdesivir, which works by interfering with the reproduction of viruses in cells, was granted emergency authorization by the FDA in May following a drug trial led by the National Institutes of Health that showed a decrease in hospital stays following treatment. The drug was not shown to be effective at reducing deaths.
But doctors stressed that the approval should not be taken as a sign that the drug is super effective.
"It is absolutely not a blockbuster drug or a miracle drug," said Megan Ranney, associate professor of emergency medicine and public health at Brown University. "We give it to hospitalized COVID patients because we don’t have anything better, which is frustrating."
A large international study published last week by the World Health Organization found that that remdesivir had no effect on the length of hospital stays, as well as no effect on deaths. The findings have yet to be peer reviewed or published in a scientific journal.
Health experts criticized the WHO study, which enrolled 12,000 patients in hundreds of hospitals across the world, saying the treatments were likely too varied to draw definitive conclusions. The study also included patients with varying degrees of illness, making it harder to know if the drug is more effective for a certain subset.
"It’s a good thing it was done in so many countries — it means it’s generalizable, but it means there were a lot of different treatments given to people at the same time," Ranney said. "But that study goes along with the fact that this is not something that is going to absolutely transform the outcome for many COVID patients. It goes along with the fact that if there is an effect, there is a small effect."
The antiviral drug, originally developed as a treatment for Ebola and hepatitis C, has nevertheless become widely used as a treatment for hospitalized patients, often given early in a patient's hospitalization. And unlike many other drugs, Ranney said, it's relatively well-tolerated and has side effects that are uncommon and easy to spot. That makes the potential benefit clearly outweigh the potential for harm.
Another drug, the steroid dexamethasone, has been shown to decrease the likelihood of deaths, but is only recommended for use in hospitalized COVID-19 patients with severe illness in need of oxygen.
Last month, President Donald Trump was given remdesivir, dexamethasone, and an antibody cocktail to treat his coronavirus infection.
The drug's manufacturer, Gilead, celebrated the FDA's announcement as a victory in the international fight against the pandemic.
"In less than one year, the world has moved from a sense of desperation to understand an unknown disease spreading all too quickly and taking lives, to one of hope that we now have enough knowledge and a growing set of tools to help fight COVID-19," said Gilead CEO Merdad Parsey. "With today’s FDA approval, and regulatory approvals or temporary authorizations in approximately 50 additional countries around the world, Veklury® (remdesivir) is one of the tools available today."
Gilead has been criticized for a global shortage of remdesivir driven in part by high demand as well as the patent held by the pharmaceutical company. In contrast, dexamethasone is cheap and widely available because it is an old drug. Earlier this month, Gilead sent thousands of doses of the drug to the EU to help manage the drug shortages.
"It’s a huge win for Gilead to have it FDA approved. But whether it’s actually going to help patients is TBD," Ranney said.
"None of us think that remdesivir is like this magical pharmaceutical," she added. "It may be that we stop using it. But we just don’t have anything else right now.