The approval makes remdesivir the first and only approved antiviral treatment for patients across all stages of renal disease.
The FDA has approved remdesivir (Veklury, Gilead) for the treatment of COVID-19 in patients with severe renal impairment, including those on dialysis, making it the first approved antiviral treatment for patients across all stages of renal disease.
The clinical benefit in hospitalized patients with COVID-19 is supported by randomized controlled trials, real-world evidence, and meta-analyses, but its use has previously been limited among patients with severe renal impairment due to insufficient data. The updated prescribing information does not require dose adjustments for renally-impaired patients and removes the requirement for estimated glomerular filtration rate (eGFR) testing before or during treatment with remdesivir.
More than 37 million Americans are estimated to have chronic kidney disease (CKD) and are at increased risk of COVID-19–related morbidity and mortality. The approval for this population was based on results from a phase 1 study, as well as results from the phase 3 REDPINE trial, which demonstrated the pharmacokinetics and safety profile of remdesivir in this population. No new safety signals were observed in either study.
“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,” said Meghan Sise, MD, in the Department of Nephrology at Massachusetts General Hospital, in a press release. “With limited clinical trial information for COVID-19 patients with advanced CKD and ESKD, few antiviral treatment options currently exist for this population.”
The REDPINE study evaluated the efficacy and safety of remdesivir in patients with severely reduced kidney function who are hospitalized with COVID-19. The trial enrolled 243 hospitalized adult participants with confirmed COVID-19 and renal impairment who were randomized 2:1 to receive remdesivir (n=163) or placebo (n=80), in addition to standard of care, and were stratified by ESKD, high-flow oxygen requirement, and region.
The study closed prematurely due to feasibility issues and was underpowered to assess for efficacy because of lower than expected enrollment. No new safety signals were observed and no additional adverse reactions with up to 5 days of remdesivir were identified in 163 hospitalized patients with confirmed COVID-19 and acute kidney injury, CKD, or ESKD requiring hemodialysis.
“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,” Sise said in the press release.
Remdesivir is a nucleotide analog that directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Based on in vitro analyses, remdesivir retains antiviral activity against recent Omicron subvariants of concern, including BQ.1.1 and XBB.
It is the antiviral standard of care for the treatment of hospitalized patients with COVID-19. It is also a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. In the United States, remdesivir is indicated for the treatment of COVID-19 in adults and pediatric patients who are either hospitalized, or not hospitalized and are at high risk for progression to severe COVID-19, including hospitalization or death.
“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 Ana Osinusi, MD, vice president of Clinical Research for Hepatitis, Respiratory, and Emerging Viruses at Gilead Sciences, in the press release.
FDA Approves Veklury (Remdesivir) for COVID-19 Treatment in Patients With Severe Renal Impairment, Including Those on Dialysis. News release. Gilead. July 14, 2023. Accessed July 14, 2023. https://www.gilead.com/news-and-press/press-room/press-releases/2023/7/fda-approves-veklury-remdesivir-for-covid19-treatment-in-patients-with-severe-renal-impairment-including-those-on-dialysis