FDA expands indication for Veklury to treat all hospitalized patients with COVID-19, in addition to the previous authorization for patients hospitalized with severe COVID-19. Gilead Sciences

Gilead Sciences, Inc. announced the FDA expanded the Emergency Use Authorization (EUA) enabling use of the investigational antiviral Veklury (remdesivir) to treat all hospitalized 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 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-1 trial in hospitalized patients with a range of disease severity. Results from the Phase III SIMPLE study were published in the Journal of the American Medical Association (JAMA) on August 21, 2020 and confirm top-line results previously announced on June 1, 2020. The primary endpoint evaluated patients at Day 11 on a 7-point ordinal scale and found patients randomized to a 5-day course of Veklury 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 Veklury 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).. See-"Effect of Remdesivir vs Standard Care on Clinical Status at 11 Days in Patients With Moderate COVID-19-A Randomized Clinical Trial";Christoph D. Spinner, MD1; Robert L. Gottlieb, MD, PhD2; Gerard J. Criner, MD3; et al-JAMA. Published online August 21, 2020. doi:10.1001/jama.2020.16349.