ST. GALLEN, SWITZERLAND & STAMFORD, CONN.-- August 19, 2022 -- Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that they have received approval for Kapruvia® from the Swiss Agency for Therapeutic Products (Swissmedic). Kapruvia® will be the first therapy available for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis patients. Swissmedic approval for Kapruvia® follows approvals by the U.S. Food and Drug Administration, by the European Medicines Agency, by the UK Medicines and Healthcare products Regulatory Agency, as well as by Health Canada.

“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 Dr. 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 Chief Executive Officer 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.”

Swissmedic approval was supported by positive data from two pivotal phase-III trials - KALM-1, conducted in the U.S. (New England Journal of Medicine 2020; 382:222-232), and the global KALM-2, as well as supportive data from an additional 32 clinical studies.

Kapruvia® has been submitted in Switzerland as part of an Access Consortium procedure together with Canada (approved in August 2022), as well as Australia and Singapore. Regulatory decisions in these two markets are expected in the second half of 2022.