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Kapruvia has been approved by the European Commission for the treatment of moderate-to-severe pruritis in hemodialysis patients.
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics announced on April 28, 2022 that the European Commission (EC) has granted marketing authorization to Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritis associated with chronic kidney disease (CKD) in adult hemodialysis patients.
The treatment was approved by FDA in the United States in August 2021 for the same indication under the name Korsuva. The EC approval allows the treatment to be used in all member states of the European Union, as well as Iceland, Liechtenstein, and Norway. According to the company, Kapruvia is the first approved therapy in Europe for the treatment of pruritis associated with CKD in hemodialysis patients. The first launches in Europe are expected in the second half of 2022.
“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, in a press release. “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.”
Source: Cara Therapeutics