Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) said that Kapruvia (difelikefalin) has secured approval from the European Commission (EC) for the treatment of moderate-to-severe pruritus linked to chronic kidney disease (CKD) in adult hemodialysis patients.

The marketing authorization enables Kapruvia to be used in all member states of the European Union along with Iceland, Norway, and Liechtenstein.

Cara Therapeutics had developed the drug and had licensed its rights to VFMCRP, which is the common company of Vifor Pharma (formerly Galenica) and Fresenius Medical Care.

According to Cara Therapeutics, Kapruvia will be the first therapy in Europe for the treatment of CKD-associated pruritus in patients with hemodialysis.

Dr. Klaus Henning Jensen — Chief Medical Officer of Vifor Pharma said: “We are very excited about the European Commission’s approval of Kapruvia, marking an important milestone on our journey to advance and fundamentally change the treatment paradigm for people living with the severe burden of pruritus associated with chronic kidney disease,” said

“We look forward to bringing this first-in-class therapy to patients in Europe, with launch in first markets expected in the second half of 2022.”

The approval of Kapruvia by the European Commission has been driven by data from a couple of phase 3 clinical trials namely KALM-1 and KALM-2, along with supportive data from 32 more clinical studies.

All the studies demonstrated that treatment with Kapruvia led to clinically meaningful improvements in the severity of pruritus and in pruritus-related quality of life components. It was also found to be generally well tolerated in patients having moderate-to-severe CKD-associated pruritus.

Dr. Joana Goncalves — Chief Medical Officer of Cara Therapeutics said: “The European Commission’s approval of Kapruvia provides a much-needed therapy to hemodialysis patients in Europe who suffer from pruritus.

“We are excited to bring an innovative drug to physicians to help change the way pruritus is managed. We continue to work with our commercial partner VFMCRP, to fill a significant unmet medical need among CKD patients with pruritus in both the U.S. and Europe.”

Last August, difelikefalin injection was approved by the US Food and Drug Administration (FDA) for the same indication. In the US, it is branded as KORSUVA and is scheduled to be launched in the second quarter of 2022.

  Cara Therapeutics, chronic kidney disease, difelikefalin, Dr. Joana Goncalves, Dr. Klaus Henning Jensen, European Commission, European Union, Fresenius Medical Care, Kapruvia, KORSUVA, VFMCRP, Vifor Fresenius Medical Care Renal Pharma, Vifor Pharma