FDA expands usage to all hospitalized COVID-19 patients.
The FDA today announced it had expanded its Emergency Use Authorization (EUA) for remdesivir (Veklury) enabling its use to treat all hospitalized patients with coronavirus 2019 (COVID-19).
Previously, the last EUA for the medication issued back in May only included he treatment of hospitalized patients with severe COVID-19.
“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,” Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences, said. “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.”
The expanded EUA is based on results from the Phase 3 SIMPLE trial evaluating remdesivir in hospitalized patients with moderate COVID-19 pneumonia, as well as results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial in hospitalized patients with a range of disease severity.
The primary endpoint evaluated patients at Day 11 on a 7-point ordinal scale and found patients randomized to a 5-day course of remdesivir plus standard of care were 65 percent more likely to have an improvement in clinical status compared with those randomized to standard of care alone (OR, 1.65; 95% confidence interval, 1.09-2.48; p=0.017).
For patients in the 10-day remdesivir group, the improvement in clinical status at Day 11 was not statistically different compared with the standard of care group (OR, 1.31; 95% confidence interval, 0.88-1.95; p=0.183).
“These study results show that patients with moderate COVID-19 disease may also benefit from a 5-day treatment course of remdesivir,” Francisco Marty, MD, an infectious diseases physician at Brigham and Women’s Hospital, and associate professor of medicine at Harvard Medical School, said.