The United States Food and Drug Administration (USFDA) has issued an emergency use authorisation (EUA) for Gilead Sciences’ experimental drug, Remdesivir to treat all hospitalised patients with Covid-19.
Gilead’s investigational antiviral Veklury (Remdesivir) had previously received authorisation for the treatment of patients hospitalised with severe Covid-19.
The FDA has now expanded the EUA to cover hospitalised patients with moderate Covid-19 as well, the company said in an official release.
The approval “is based on results from the Phase 3 SIMPLE trial evaluating Veklury in hospitalised 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,” it said.
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 the 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.”
In India, the company has licensed the drug for manufacturing and sale to Cipla, Hetero Drugs Ltd, Zydus Cadila, Biocon, Dr Reddy’s Laboratories, Mylan, Jubilant Life Sciences, and Syngene International Ltd.
Syngene and Dr Reddy’s are yet to launch their version of the drug.