Vifor Fresenius Medical Care Renal Pharma (VFMCRP) 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. If approved, Kapruvia® would receive marketing authorization in all member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway.