Gilead Sciences has secured expanded emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its investigational antiviral Veklury (remdesivir) to treat not only hospitalised patients suffering from severe COVID-19, but also those who were moderately afflicted.
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.