Gilead had already secured EUA status for Veklury for the treatment of patients hospitalised due to severe Covid-19.
The expanded EUA status was granted based on data from the phase 3 SIMPLE trial, which is assessing Veklury in hospitaliased patients with moderate Covdi-19 pneumonia.
The US regulator has also evaluated data from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial in hospitalised patients with a range of disease severity to grant the status.
The two-phase 3 randomised, open-label, multi-centre and international clinical trials, dubbed SIMPLE studies, have been launched by the company to evaluate Veklury in countries with a high prevalence of Covid-19 infections.
Gilead’s first SIMPLE study is assessing the safety and efficiency of five-day and 10-day dosing durations of Veklury administered intravenously in hospitalised patients with severe manifestations of Covid-19.
The company randomsied 397 patients in a 1:1 ratio in the initial phase of the study to secure either a five-day or a 10-day treatment course of Veklury, apart from standard of care
Its second SIMPLE trial is assessing the safety and efficacy of five-day and 10-day dosing durations of Veklury administered intravenously in hospitalised patients with moderate manifestations of Covid-19, compared with standard of care.
Gilead has randomised 600 patients in a 1:1:1 ratio in the initial phase of the study to secure either a five-day or a 10-day treatment course of Veklury in addition to standard of care, in addition to standard of care.
Gilead Sciences chief medical officer Dr Merdad Parsey said: “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 authorisation.”
In July this year, Gilead Sciences secured conditional marketing authorisation from the European Commission for its Veklury to treat Covid-19 disease.