EMA panel grants positive opinion for Remdesivir use in COVID patients with severe renal impairment, including those on dialysis: Gilead Sciences
Foster City: Gilead Sciences, Inc. has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has 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.
“COVID-19 continues to pose a threat to the lives of vulnerable individuals, including those with renal impairment,” said Anu Osinusi, Vice President, Clinical Research for Hepatitis, Respiratory and Emerging Viruses, Gilead Sciences. “Gilead’s commitment to address the unmet needs of the most susceptible populations remains a top priority. We are encouraged by the CHMP opinion and will continue to invest in developing suitable treatment options for populations at risk of severe disease.”
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 (<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 3 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.
“The positive opinion from the Committee helps validate the safety profile of Veklury in people with severe renal impairment,” said Prof. Dr. Tobias Welte, Professor of Pulmonary Medicine and Director of the Department of Pulmonary and Infectious Diseases at Hannover University School of Medicine. “Expanding the use of Veklury in this population, which still has limited treatment options, will help more people gain access to treatment for COVID-19.”
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