FDA approves Gilead’s remdesivir as first coronavirus treatment

Remdesivir is the first drug to gain FDA approval as a COVID-19 treatment, the agency announced on Thursday.

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.”