Committee Recommends Remdesivir to Treat COVID-19 in People With Severe Kidney Disease
European medical committee offers favorable opinion for people with all forms of renal impairment including those on dialysis.
Photo credit: Julien Tromeur
Late last week, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency granted a positive opinion for the use of remdesivir (Veklury) in COVID-19 patients with severe renal impairment, including those patients on dialysis. This committee is presented with data and then offers its opinion on therapies and whether they think it should be indicated for specific uses. Upon this opinion, the European Commission votes to decide on approval of the indication within this patient population.
If adopted, remdesivir will become the first and only authorized antiviral COVID-19 treatment that can be used across all stages of renal disease.
It is believed that as many as 75 million people in Europe have chronic kidney disease.
“COVID-19 continues to pose a threat to the lives of vulnerable individuals, including those with renal impairment,” Anu Osinusi, vice president, Clinical Research for Hepatitis, Respiratory and Emerging Viruses, Gilead Sciences, said in a statement. “We are encouraged by today’s CHMP opinion and will continue to invest in developing suitable treatment options for populations at risk of severe disease.”
What the Data Says
This positive opinion for use in people with severe renal impairment was based on results from a phase 1 pharmacokinetic study, as well as results from the phase 3 REDPINE trial that evaluated the safety of remdesivir 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 Tobias Welte, MD, 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.”
