The Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Veklury® (remdesivir) to include the treatment of COVID-19 in patients with severe impairment, including those on dialysis.
Veklury, a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor, is indicated for the treatment of COVID-19 in adults and pediatric patients (28 days of age and older and weighing at least 3kg) who are: hospitalized, or not hospitalized and have mild to moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
Previously, Veklury was not recommended in patients with an estimated glomerular filtration rate (eGFR) less than 30mL per minute. The updated labeling now states that dosage adjustments are not required in patients with any degree of renal impairment and the drug may be administered without regard to the timing of dialysis.
The approval was supported by data from a phase 1 pharmacokinetics study, along with findings from the phase 3 REDPINE trial (ClinicalTrials.gov Identifier: NCT04745351). The REDPINE trial included 243 hospitalized adults with confirmed COVID-19 and renal impairment, including 90 patients with acute kidney injury, 64 with chronic kidney disease (CKD), and 89 with end-stage renal disease.
Participants were randomly assigned 2:1 to receive Veklury (n=163) or placebo (n=80), plus standard of care. No new safety signals or additional adverse reactions were observed in the study. According to Gilead, the study closed prematurely due to feasibility issues and was underpowered to assess for efficacy.
“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, Clinical Research for Hepatitis, Respiratory and Emerging Viruses at Gilead Sciences.
This article originally appeared on MPR