CHMP adopts positive opinion to extend the use of Veklury to treat COVID-19 in people with severe renal impairment, including those on dialysis
Gilead Sciences, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) granted a positive opinion for the use of Veklury (remdesivir) in COVID-19 patients with severe renal impairment, including those on dialysis. The European Commission (EC) will review the CHMP recommendation and, if adopted, Veklury will become the first and only authorized antiviral COVID-19 treatment that can be used across all stages of renal disease
In Europe, approximately 75 million people suffer from chronic kidney disease (CKD). Patients with advanced CKD or end stage kidney disease (ESKD) represent a population that is highly vulnerable to COVID-19. They are at increased risk of morbidity and mortality from COVID-19, with mortality rates as high as 21-25%, and currently have limited treatment options that are safe and effective.
The clinical benefit of Veklury in hospitalized populations with COVID-19 is supported by randomized controlled trials, real-world evidence and meta-analyses, but its use has previously been restricted among patients with severe renal impairment ( less than 30mL/min) due to insufficient data.
This positive opinion for use in people with severe renal impairment was based on results from a Phase 1 Pharmacokinetic study (GS-US-540-9015), as well as results from the Phase III REDPINE trial that evaluated the safety of Veklury in patients hospitalized for COVID-19 with severe renal impairment. No new safety signals were observed in either of the studies.
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