Cara Therapeutics Secures Swiss Regulatory Approval For Chronic Kidney Disease Candidate

The Swiss Agency for Therapeutic Products (Swissmedic) has approved Cara Therapeutics’ CARA lead candidate KORSUVA (difelikefalin) injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis patients.

The regulatory approval was supported by positive data from pivotal phase-III trials – KALM-1, conducted in the United States and the global KALM-2, as well as supportive data from an additional 32 clinical studies.

The regulatory submission of Kapruvia in Switzerland was a part of an Access Consortium procedure together with Canada as well as Australia and Singapore.

Kapruvia (difelikefalin) is the first and only therapy approved through consortium filing for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients.

The Health Canada has approved the lead drug in the month of August 2022, while decision from Australia and Singapore regulatory authorities are expected in the second half of 2022.

Kapruvia was previously approved by the U.S. Food and Drug Administration in the United States, by the European Medicines Agency in the European Union and by the UK Medicines and Healthcare products Regulatory Agency in the United Kingdom.

Christopher Posner, President and Chief Executive Officer, said, "We are pleased that Kapruvia is now approved in Switzerland for hemodialysis patients who are suffering from CKD-associated pruritus. 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."

Chronic Kidney Disease-associated Pruritus is an intractable systemic itch condition that occurs with high frequency and intensity in patients with chronic kidney disease undergoing dialysis.

Price Action : Cara shares are trading around 3 percent higher at $11.40 on Friday during pre-market session.