Kapruvia Receives Positive CHMP Opinion for the Treatment of Moderate-to-Severe Pruritus in Hemodialysis Patients

Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics, have 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 companies explained that 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 recommendation is another major step forward on our mission to help kidney patients around the world lead better, healthier lives,” said Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. “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.”

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

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, Vifor and Cara said.

If approved, Kapruvia would receive marketing authorization in all member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway.