Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics have announced that the European Commission has granted marketing authorization to Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adult hemodialysis patients.
The marketing authorization, which approves Kapruvia for use in all member states of the European Union plus Iceland, Liechtenstein and Norway, follows the U.S. Food and Drug Administration (FDA) approval of KORSUVA (difelikefalin) injection in August 2021 for the same indication. Kapruvia will be the first therapy available in Europe for the treatment of CKD-associated pruritus in hemodialysis patients.
“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 Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. “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 European Commission’s approval of Kapruvia provides a much-needed therapy to hemodialysis patients in Europe who suffer from pruritus,” said Dr. Joana Goncalves, Chief Medical Officer of Cara Therapeutics. “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.”
The approval in Europe 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-associated pruritus, the companies said.