The approval was based on findings from a Phase 1 study, as well as results from the Phase 3 REDPINE trial in which Veklury showed a strong PK and safety profile in patients with severe renal impairment
FDA clears Veklury for Covid-19 treatment in renal impairment patients. (Credit: Daniel Roberts from Pixabay)
Gilead Sciences has announced that the US Food and Drug Administration (FDA) has authorised the supplemental new drug application (sNDA) for the use of Veklury (remdesivir) in Covid-19 patients with severe renal impairment, including those receiving dialysis.
Veklury is a nucleotide analogue based on Gilead’s antiviral research. It directly inhibits viral replication in the cell by targeting the SARS-CoV-2 viral RNA polymerase.
It is said to be the first and only antiviral Covid-19 medication that has been given approval and is suitable for use in all stages of renal illness.
The approval was based on findings from a Phase 1 study and results from the Phase 3 REDPINE trial.
According to the results, Veklury showed a strong pharmacokinetics (PK) and safety profile in patients with severe renal impairment. Additionally, no new safety signals were found in either of the studies.
Gilead Sciences Clinical Research for Hepatitis, Respiratory and Emerging Viruses VP Anu Osinusi said: “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.
“Gilead is committed to discovering, developing and providing transformational therapies for Covid-19, including for the most vulnerable populations at risk of developing severe disease.”
The randomized, double-blind, placebo-controlled, parallel-group, multicentre REDPINE trial evaluated the safety and efficacy of Veklury.
It recruited 243 hospitalised adult participants with confirmed Covid-19 and renal impairment. They were randomised to receive Veklury or a placebo in a 2:1 manner.
They also received standard of care and were stratified by ESKD, high-flow oxygen requirement, and region.
The pharmacokinetic data were also generated from Phase 1 open-label, parallel-group, single-dose study.
The US clearance follows the European Commission’s June 26, 2023 decision to extend Veklury’s approved use to treat COVID-19 in patients with severe renal impairment, including those receiving dialysis.
In the US, nucleotide analogue drug is indicated for treating Covid-19 in adults and paediatric patients.