FDA Expands Remdesivir Approval for Patients at Risk of Severe COVID-19 Disease

Gilead’s remdesivir was granted expanded FDA approval to treat non-hospitalized adult and adolescent patients at high risk of severe or fatal COVID-19 disease progression.

Gilead Sciences announced yesterday that the US Food and Drug Administration (FDA) approved their supplemental new drug application for remdesivir (Veklury) to treat non-hospitalized adult and adolescent patients at high risk of severe or fatal COVID-19.

Remdesivir is currently the standard of care to treat patients hospitalized with COVID-19. With the expanded indication, remdesivir can now be administered in qualified outpatient settings via intravenous (IV) infusions over a 3-day period to prevent hospitalization.

In the US, remdesivir is indicated to treat COVID-19 in adults and adolescents 12 years and older and weighing at least 40 kg who are hospitalized or not hospitalized and at high risk of severe or fatal COVID-19 disease progression.

The extended approval was granted based on results from the PINETREE phase 3 randomized, placebo-controlled, double-blind trial. The trial analyzed 562 participants randomly assigned 1:1 to receive either remdesivir or placebo. The results suggested that remdesivir recipients had an 87% risk reduction of COVID-19 hospitalization or death. No deaths were observed in either arm by the day 28 endpoint, and the safety profile was similar between remdesivir and placebo. The most commonly remdesivir adverse events, reported by ≥5% recipients, were headache and nausea.

“Remdesivir has now helped to treat more than 10 million people around the world with COVID-19 and continues to play a key role in helping to reduce the burden of the pandemic. Based on the most recent data, we now understand that remdesivir is also effective in the early stages of COVID-19 infection, in addition to helping patients who are hospitalized with the disease,” said Daniel O’Day, chairman and chief executive officer of Gilead Sciences.

Unlike monoclonal antibody treatment, remdesivir targets the viral RNA polymerase, remaining active against COVID-19 variants of concern. Gilead notes that no major genetic changes have been identified in any known variants of concern, including the Delta and Omicron variants, that would affect remdesivir’s ability to target the viral RNA polymerase.