The EUA expands Veklury’s previous authorisation to treat hospitalised patients with Covid-19 regardless of oxygen status
FDA grants expanded EUA for remdesivir. (Credit: Visuals3D from Pixabay)
Gilead Sciences received an expanded US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its investigational antiviral Veklury (remdesivir) to treat hospitalised Covid-19 patients.
The expanded FDA EUA extends the previous authorisation for Veklury to treat hospitalised patients with severe Covid-19.
Veklury is Gilead’s investigational nucleotide analogue that has wide-ranging antiviral activity in both in vitro and in vivo animal models against various emerging viral pathogens.
The safety and efficacy of the drug in treating SARS-CoV-2 infection is being evaluated in several international Phase 3 clinical trials, in different patient populations, formulations, and in combination with other therapies, said the company.
Gilead Sciences chief medical officer 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 EUA.
“As we learn more about Covid-19 and further establish the efficacy and safety profile of Veklury, we see the benefit of 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.”
FDA expanded EUA for Veklury based on Phase 3 SIMPLE and ACTT-1 trial results
Gilead said that the expansion of FDA authorisation is supported by results from the Phase 3 SIMPLE trial, which evaluated Veklury in hospitalised patients with moderate Covid-19 pneumonia, along with results from the National Institute of Allergy and Infectious Diseases (NIAID) ACTT-1 trial.
The Phase 3 SIMPLE trial evaluated the safety and efficacy of Veklury in 5-day and 10-day dosing durations administered intravenously, versus standard of care.
The study results published in the Journal of the American Medical Association (JAMA) showed that that the drug was generally tolerated well in both the 5-day and 10-day treatment groups.
The most commonly reported adverse effects in the 5-day, 10-day, and standard of care groups, include nausea, diarrhoea, hypokalaemia, and headache.
The company said that Veklury is an investigational drug that has not been approved in the US, and the safety and efficacy of the drug to treat Covid-19 have not been established.
Harvard Medical School associate professor of medicine Francisco Marty said: “As our understanding of the spectrum of SARS-CoV-2 infection and the presentations and severity of Covid-19 continues to evolve, these results and the expanded EUA represent a new, important step that streamlines bedside prescribing of remdesivir without having to wait for patients to worsen clinically.
“These study results show that patients with moderate Covid-19 disease may also benefit from a 5-day treatment course of remdesivir.”