FDA expands Veklury emergency use in COVID-19 patients

On Friday, as part of its ongoing efforts to fight COVID-19, the US Food and Drug Administration broadened the scope of the existing emergency use authorization for Veklury (remdesivir) to include treatment of all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19, irrespective of their severity of disease.

In  May 2020, the FDA issued an EUA that authorized US biotech major Gilead Sciences’ (Nasdaq: GILD) Veklury for the treatment of hospitalized adult and pediatric patients with severe COVID-19. As noted in the initial issuance of the EUA, the emergency use of Veklury was limited to those patients with severe disease, which was defined as patients with low blood oxygen levels or needing oxygen therapy or more intensive breathing support such as a mechanical ventilator.

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