EMA Committee grants positive opinion for Veklury use to treat COVID 19 in people with Hepatic impairment

The clinical benefit of Veklury in hospitalized populations with COVID-19 is supported by randomized controlled trials, real-world evidence and meta-analyses, but the pharmacokinetics of Veklury had not previously been evaluated in patients with hepatic impairment. This positive opinion was based on results from a Phase 1 study of safety and pharmacokinetics in people with hepatic impairment (GS-US-540-9014). Based upon these results, the revised recommendation requires no dose adjustment or liver function testing before or during treatment with Veklury.

“The positive opinion from the Committee helps validate the safety profile of Veklury and is reassuring news to vulnerable populations, such as those living with liver disease that may be facing an increased risk of complications from COVID-19,” said Antonella Castagna, MD, Head of Infectious Diseases at San Raffaele Scientific Institute; Professor, Clinic of Infectious Diseases, Vita-Salute San Raffaele University. “Expanding the use of Veklury to those with hepatic impairment will help more people gain access to treatment for COVID-19.”

This positive opinion follows recent approvals in the U.S. and the EU which extended the approval of Veklury to treat COVID-19 in people with renal and hepatic impairment.