FDA Approves Veklury (Remdesivir) to Treat COVID-19 in People With Mild to Severe Hepatic Impairment With no Dose Adjustment

Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury (remdesivir) with no dose adjustments to treat COVID-19 in people with mild, moderate and severe hepatic impairment. This approval further supports the safety profile of Veklury as the first and only approved antiviral COVID-19 treatment that can be used across all stages of liver disease.

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 latest approval is based on results from a Phase 1 study of safety and pharmacokinetics in people with hepatic impairment (GS-US-540-9014). No new safety signals were observed. Based upon these results, the label has been updated to reflect that no dose adjustment is required across all stages of liver disease. The label still recommends initial hepatic laboratory testing in all patients, before starting Veklury and during treatment as clinically appropriate, and that discontinuation be considered if alanine transaminase (ALT) levels increase to 10 times the upper limit of normal or if ALT elevation is accompanied by signs or symptoms of liver inflammation.

More than 100 million people in the U.S. are living with liver disease. Furthermore, people with liver disease represent a population that is vulnerable to COVID-19 and are at increased risk of morbidity and mortality. People with severe liver disease currently have limited treatment options for COVID-19.

“With the recent increase in levels of COVID-19 circulating in the U.S., the risk to vulnerable individuals persists, including for those with hepatic impairment,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head at Gilead Sciences. “This approval demonstrates Gilead’s ongoing commitment to COVID-19, including our focus on vulnerable populations.”

“The update to the safety profile and dosing recommendations for Veklury for those living with liver disease is important to this vulnerable population who faces an increased risk of complications from COVID-19,” said Douglas Dieterich, MD, Director, Institute for Liver Medicine, Professor of Medicine, Division of Liver Diseases, Icahn School of Medicine at Mount Sinai. “While COVID-19 is no longer a public health emergency, the virus continues to present a threat to those with underlying conditions.”

This approval follows the recent FDA and European Commission decisions to extend the approved use of Veklury to treat COVID-19 in people with severe renal impairment, including those on dialysis.

Gilead’s ongoing research in the most vulnerable patient populations with high unmet need is a testament to the company’s commitment to COVID-19 and this approval further validates Veklury’s overall safety profile.