Gilead’s Remdesivir Gains Full FDA Approval for COVID-19

The FDA on Thursday granted full approval to Gilead Sciences’ Veklury (remdesivir) to treat hospitalized COVID-19 patients, making it the first approved COVID-19 treatment in the U.S.

Clearly sensitive to charges that the approval was rushed through the agency in response to pressure from the Trump administration ahead of the Nov. 3 presidential election, FDA Commissioner Stephen Hahn said the approval “is supported by data from multiple clinical trials that the agency has rigorously assessed.”

The antiviral works to stop replication of the SARS-CoV-2 virus that causes COVID-19 infections. The approval is limited to adult patients and children age 12 and up weighing at least 88 pounds.

The drug certainly advanced rapidly through the FDA review process. The agency granted remdesivir an Emergency Use Authorization on May 1 to treat hospitalized patients with severe COVID-19 (DID, May 4), and the company filed a new drug application (NDA) for a full approval on Aug. 10. But the agency did not wait for the full NDA application, instead launching a review in early April based on early data.

The agency said it based the approval on results from three clinical trials that included patients hospitalized with mild-to-severe COVID-19.  One conducted by the NIH’s National Institute of Allergy and Infectious Diseases found that the median time to recovery from COVID-19 was 10 days for the Veklury group compared to 15 days for the placebo group.

A second trial found that the odds of a subject’s COVID-19 symptoms improving were statistically significantly higher in the Veklury group at Day 11 when compared to those receiving only standard of care.

A third trial of hospitalized adults with severe COVID-19 found the odds of a subject’s COVID-19 symptoms improving were similar for those in the five-day dosing Veklury group and for those in the 10-day dosing Veklury group, and there were no statistically significant differences in recovery rates or mortality rates between the two groups.

Gilead is expected to release more supporting data this week.

The company had rejected findings from the World Health Organization’s Solidarity trial showing remdesivir had “little or no effect” on hospitalized COVID-19 patients, criticizing the trial’s design and noting that findings hadn’t gone through a peer review (DID, Oct. 19).

Remdesivir has been conditionally approved in multiple countries to treat COVID-19. Before the pandemic, the antiviral was being studied as a treatment for Ebolavirus infections but was not approved for any use.

Gilead said the drug is now “widely available in hospitals across the country, following early investments to rapidly expand manufacturing capacity to increase supply.” — Martin Berman-Gorvine