FDA Approves COVID-19 Treatment for Patients With Severe Renal Impairment, Including Those on Dialysis

Gilead Sciences, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for the use of Veklury® (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis.

With this approval, Veklury is now the first and only approved antiviral COVID-19 treatment that can be used across all stages of renal disease.

This is essential news since more than 37 million people in the U.S. are estimated to have chronic kidney disease (CKD) and are at increased risk of COVID-19-related morbidity and mortality.

The FDA approval follows the European Commission's decision to extend the approved use of Veklury on June 26, 2023.

"Patients with advanced CKD and end-stage kidney disease (ESKD) are at high risk for severe COVID-19 with hospitalization and mortality rates remaining high, even for those who are vaccinated. With limited clinical trial information for COVID-19 patients with advanced CKD and ESKD, few antiviral treatment options currently exist for this population," said Meghan Sise, MD, Department of Nephrology at Massachusetts General Hospital, in a press release on July 14, 2023.

"This latest update to the prescribing information for remdesivir now includes patients with advanced CKD and ESKD, and this is an important advance for a population that remains highly vulnerable to the impacts of COVID-19."

The updated prescribing information for Veklury announced today does not require dose adjustments for renal-impaired patients and removes the requirement for eGFR testing before or during treatment with Veklury.