In a major breakthrough, Gilead’s remdesivir (Veklury) becomes the first COVID-19 antiviral to be FDA-approved for patients with severe renal disease.
Today, Gilead Sciences, Inc announced the US Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for remdesivir (Veklury) for COVID-19 patients with severe renal impairment, including those on dialysis. The approval makes remdesivir the first and only approved antiviral COVID-19 treatment for patients with all stages of renal disease.
Remdesivir was the first COVID-19 drug to receive FDA approval, and the broad-spectrum antiviral is often the standard of care for hospitalized COVID-19 patients. However, the estimated 1 in 7 people (37 million in the US) with chronic kidney disease (CKD) and an elevated risk of COVID-19 morbidity and mortality can now reap the benefits of this treatment.
“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,” explained Meghan Sise, MD, of the Massachusetts General Hospital Department of Nephrology. “With limited clinical trial information for COVID-19 patients with advanced CKD and ESKD, few antiviral treatment options currently exist for this population. 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 FDA approval comes shortly after remdesivir was approved by the European Commission to treat COVID-19 in patients with severe renal impairment, on June 26, 2023. Both approvals were based upon positive results from the phase 1 study GS-US-540-9015, as well as the phase 3 REDPINE trial, which demonstrated the pharmacokinetics and safety of remdesivir for COVID-19 patients with severe renal impairment.
In the US, remdesivir is approved to treat COVID-19 in adults and children (at least 28 days old and 3 kg) who are hospitalized, or who are at high risk of severe or fatal COVID-19 disease progression.
Remdesivir is a nucleotide analog invented by Gilead and based in more than a decade of antiviral research. The antiviral inhibits COVID-19 viral replication inside of the cell by targeting the viral RNA polymerase. In vitro analyses suggest remdesivir retains antiviral activity against recent Omicron subvariants of concern, including BQ.1.1 and XBB.
“The approval by the FDA of Veklury for the treatment of patients with renal impairment reflects the urgency to make this medicine available to these patients, and underscores the established safety profile for Veklury,” said Anu Osinusi, Vice President of Clinical Research for Hepatitis, Respiratory and Emerging Viruses at Gilead Sciences.