VFMCRP, Cara: Kapruvia Approved In Switzerland To Treat Hemodialysis Patients
Vifor Fresenius Medical Care Renal Pharma or VFMCRP and Cara Therapeutics, Inc. (CARA), a commercial-stage biopharmaceutical company, announced Friday 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 was supported by positive data from two pivotal phase-III trials – KALM-1, conducted in the U.S. , and the global KALM-2, as well as supportive data from an additional 32 clinical studies.
The drug has been submitted in Switzerland as part of an Access Consortium procedure together with Canada, which was approved in August 2022, as well as Australia and Singapore. Regulatory decisions in these two markets are expected in the second half of 2022.
Kapruvia has already received approvals from the U.S. Food and Drug Administration, the European Medicines Agency, the UK Medicines and Healthcare products Regulatory Agency, as well as Health Canada.
Klaus Henning Jensen, Chief Medical Officer of CSL Vifor, said, “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.”
VFMCRP is a joint venture between CSL Vifor, owned by Australia’s CSL (CSL.AX, CSLLY) and Fresenius Medical Care (FMS).
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