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

Europe has the highest burden of liver disease in the world and cases are expected to grow across many countries. Furthermore, people with liver disease represent a population that is highly vulnerable to COVID-19 and are at increased risk of morbidity and mortality. Safety data in people with severe hepatic impairment are limited and there are few treatment options that are safe and effective.

“Despite lower levels of COVID-19 circulating in the European Union (EU) than at the height of the pandemic, the disease continues to persist and pose a real risk to vulnerable individuals, including those with hepatic impairment,” said Anu Osinusi, Vice President, Clinical Research for Hepatitis, Respiratory and Emerging Viruses, Gilead Sciences. “Thepositive CHMP opinion reflects Gilead’s ongoing commitment to addressing the unmet needs of those most susceptible to COVID-19.”

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.