Press release
FDA Approves Veklury® (Remdesivir) to Treat COVID-19 in People With Mild to Severe Hepatic Impairment With no Dose Adjustment
-- This Approval Supports Veklury’s Strong Safety Profile and Makes Veklury the Only Approved COVID-19 Antiviral Treatment Across all Stages of Liver Disease
About this update from Gilead Sciences, Inc.
[{"type":"text","content":"\n-- This Approval Supports Veklury’s Strong Safety Profile and Makes Veklury the Only Approved COVID-19 Antiviral Treatment Across all Stages of Liver Disease --\n\n\n FOSTER CITY, Calif.--(BUSINESS WIRE)--\nGilead Sciences, Inc. (Nasdaq: GILD) today 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.\n\n\nThe 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.\n\n\nMore 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.\n\n\n“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.”\n\n\n“The update to the safety profile and dosing recomme...