Treatment for Moderate-to-Severe CKD-Associated Pruritus Gains Swiss Approval

Kapruvia (difelikefalin) has been granted approval by Swissmedic as a treatment for moderate-to-severe pruritis associated with CKD.

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics have announced that Kapruvia (difelikefalin) has been granted approval by the Swiss Agency for Therapeutic Products (Swissmedic) as a treatment for moderate-to-severe pruritis associated with chronic kidney disease (CKD) in adult hemodialiysis patients.

The Swiss approval of Kapruvia, which was revealed in an Aug. 19, 2022 press release, follows on from the approval in the United States, Europe, and United Kingdom, as well as Canada. Swissmedic’s decision was supported by positive data from two Phase III clinical trials and an additional 32 clinical studies.

“The approval of Kapruvia in Switzerland is the next step on our journey to bring this breakthrough treatment to hemodialysis patients living with CKD-associated pruritus around the world,” said Klaus Henning Jensen, chief medical officer of CSL Vifor. “There is a high unmet medical need for a targeted therapy to treat moderate-to-severe pruritus, and we are convinced that Kapruvia can provide relief to many suffering from this heavy burden. We are very committed to making this therapy available to patients as soon as possible.”

“We are pleased that Kapruvia is now approved in Switzerland for hemodialysis patients who are suffering from CKD-associated pruritus,” said Christopher Posner, president and CEO of Cara Therapeutics. “As Cara Therapeutics continues on the path toward becoming the leader in the treatment of chronic pruritus, we are working with our partner VFMCRP to ensure this first-of-its-kind therapy is available to healthcare providers and patients across the globe who greatly need a treatment option.”

Source: CSL Vifor