The US Food and Drug Administration (USFDA) on October 22 gave its final nod to Gilead’s antiviral drug Remdesivir for treating hospitalized Covid-19 patients. Remdesivir is the first approved Covid-19 treatment in the United States.
“The FDA is committed to expediting the development and availability of Covid-19 treatments during this unprecedented public health emergency,” said FDA Commissioner Stephen Hahn, in a statement.
“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,” he added.
The agency concluded that Remdesivir demonstrated efficacy in treating hospitalized patients with Covid-19.
On May 1, 2020, the USFDA issued an Emergency Use Authorization (EUA) for Remdesivir sold under brand name Veklury for the treatment of laboratory confirmed Covid-19 in adult and pediatric patients hospitalized with severe disease.
The approval of Remdesivir was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.
The USFDA does have certain limitations on the drug. Remdesivir is not yet approved for children under 12 years old. The USFDA noted in its review that there still wasn’t good data on how the drug would affect children, people who are pregnant, or anyone with kidney or liver issues, and it also mentions that there isn’t good data on interactions between drugs.
USFDA identified hepatotoxicity as major safety issue with the drug.
Remdesivir works by blocking viruses from making copies of themselves. It was first developed by Gilead to treat Ebola and research over the past few years showed that it could block the coronaviruses SARS and MERS from replicating inside cells.