Kapruvia receives positive CHMP opinion for the treatment of moderate-to-severe pruritus in hemodialysis patients

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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, according to Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. The European Commission’s ultimate decision on marketing permission for Kapruvia is based on the CHMP view. If authorised, Kapruvia will be the first medicine available in Europe for the treatment of hemodialysis patients with chronic kidney disease-associated pruritus (CKD-aP).

“The positive CHMP recommendation is another major step forward on our mission to help kidney patients around the world lead better, healthier lives. Kapruvia has demonstrated important clinical benefits to significantly relieve patients of the severe burden of chronic kidney disease-associated pruritus, a condition that has been historically underdiagnosed and undertreated. We look forward to the European Commission decision anticipated in Q2 2022, and to bringing a therapy with the potential to advance treatment of CKD-aP to patients in Europe,” 

said Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. 

“We are pleased to have received the positive CHMP opinion, which brings us one step closer to making a treatment option available to hemodialysis patients in Europe who suffer from pruritus, Together with our partner VFMCRP, we look forward to the European Commission decision in the second quarter of 2022 and to the commercial launch of KORSUVA (difelikefalin) injection in the United States in April 2022. These are major milestones on Cara Therapeutics’ path to being a category-defining leader in the treatment of pruritus,” 

said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics.  

The favorable CHMP view is based on pivotal clinical data from the KALM-1 and KALM-2 phase-III trials, as well as supportive evidence from an additional 32 clinical investigations. In these studies, individuals with moderate-to-severe CKD-aP experienced clinically relevant improvements in pruritus severity and pruritus-related quality of life components, and Kapruvia was shown to be generally well-tolerated.

Kapruvia would be permitted for commercialization in all European Union (EU) member states, as well as Iceland, Liechtenstein, and Norway, if approved.

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