The US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) enabling use of the investigational antiviral Veklury (remdesivir) to treat all hospitalised patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19.
The expanded EUA is based on results from the Phase 3 SIMPLE trial evaluating Veklury in hospitalised patients with moderate COVID-19 pneumonia, as well as results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial in hospitalised patients with a range of disease severity.
“With the growing understanding of the utility of Veklury to help improve outcomes for a range of patients with COVID-19, we welcome the FDA’s decision to expand emergency use authorization,” said Merdad Parsey, Chief Medical Officer at Gilead Sciences, the makers of Veklury.
“As we learn more about COVID-19 and we further establish the efficacy and safety profile of Veklury, we see benefit to making the drug available to patients at earlier stages of the disease. Today’s action by the FDA enables physicians to consider a broader range of eligible patients to potentially receive Veklury.”