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.”
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