Kapruvia receives positive CHMP opinion for pruritus in hemodialysis patients

pharmafile | February 28, 2022 | News story | Sales and Marketing  

The CHMP has approved Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in hemodialysis patients. If approved by the EC, Kapruvia will be the first therapy available in Europe for the treatment of chronic kidney disease-associated pruritis.

The positive CHMP opinion is based on pivotal clinical data from two Phase III trials, KALM-1 and KALM-2, along with supportive data from 32 clinical studies. The results demonstrated that treatment with Kapruvia resulted in clinically meaningful improvements in pruritus severity and in pruritus-related quality of life. If approved, then Kapruvia would receive marketing authorisation in all member states of the EU, as well as in Iceland, Liechtenstein, and Norway.

“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, CMO 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 EC decision anticipated in Q2 2022, and to bringing a therapy with the potential to advance treatment of CKD-aP to patients in Europe.”

Christopher Posner, President and CEO of Cara Therapeutics, shared: “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 US in April 2022. These are major milestones on Cara Therapeutics’ path to being a category-defining leader in the treatment of pruritus.”

Lina Adams

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