CHMP positive for Kapruvia to treat pruritus associated with chronic kidney disease in hemodialysis patients. - Vifor Fresenius + Cara Therapeutics.
Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics, Inc. announced that the European Medicines Agency’s (EMA) CHMP has recommended approval of Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in hemodialysis patients. The CHMP opinion is the basis for the European Commission’s final decision regarding marketing authorization for Kapruvia. If approved, Kapruvia will be the first therapy available in Europe for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis patients.
The positive CHMP opinion is based on pivotal clinical data from two phase-III trials, KALM-1 and KALM-2, as well as supportive data from an additional 32 clinical studies. These studies showed that treatment with Kapruvia resulted in clinically meaningful improvements in pruritus severity and in pruritus-related quality of life components and was found to be generally well tolerated in patients with moderate-to-severe CKD-aP.
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