FDA Expands EUA for Remdesivir

On Aug. 28, 2020, FDA expanded the emergency use authorization (EUA) for Gilead Sciences’ investigational antiviral drug Veklury (remdesivir) to allow treatment of all hospitalized patients with COVID-19; the initial EUA issued on May 1 applied to patients hospitalized with low blood oxygen levels or those needing oxygen therapy or more intensive breathing support such as a ventilator.

The expanded EUA is based on results from a Phase III trial evaluating Veklury in hospitalized patients with moderate COVID-19 pneumonia, and a National Institute of Allergy and Infectious Diseases trial in hospitalized patients with a range of disease severity.

"As our understanding of the spectrum of SARS-CoV-2 infection and the presentations and severity of COVID-19 continues to evolve, these results and the expanded EUA represent a new, important step that streamlines bedside prescribing of remdesivir without having to wait for patients to worsen clinically,” said Francisco Marty, MD, an infectious diseases physician at Brigham and Women’s Hospital and associate professor of medicine at Harvard Medical School, in a Gilead Sciences press release. “These study results show that patients with moderate COVID-19 disease may also benefit from a five-day treatment course of remdesivir.”

In a statement, FDA noted, “based on the Agency’s ongoing review of the EUA, including its review of the totality of scientific information now available, the FDA has determined that it is reasonable to believe Veklury may be effective for the treatment of suspected or laboratory-confirmed COVID-19 in all hospitalized adult and pediatric patients. The Agency’s review has also concluded that the known and potential benefits of Veklury outweigh the known and potential risks for these uses.”

Sources: Gilead Sciences; FDA