Kapruvia (difelikefalin) recommended by England’s NICE for the treatment of adults with moderate-to-severe CKD-associated pruritus

Recommendation will enable eligible patients in England, Wales and Northern Ireland to access the first licensed treatment for moderate-to-severe chronic kidney disease (CKD)-associated pruritus in adult patients on haemodialysis

ST. GALLEN, Switzerland and STAMFORD, Conn., May 18, 2023 (GLOBE NEWSWIRE) -- Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that England’s National Institute for Health and Care Excellence (NICE) has recommended Kapruvia for the treatment of moderate-to-severe CKD-associated pruritus in adult patients on haemodialysis. The decision follows authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in April 2022.

“The recommendation of Kapruvia by NICE is a key step on our journey to bring this breakthrough treatment to in-centre haemodialysis patients living with moderate-to-severe CKD-associated pruritus in the UK,” said Fabio Dorigotti, Head Global Medical Affairs of CSL Vifor. “We look forward to continue working with the National Health Service to ensure access to this important medicine for patients as quickly as possible.”

“We are pleased that Kapruvia will be available to CKD patients in England, Wales and Northern Ireland who are undergoing haemodialysis and suffering from moderate-to-severe CKD-associated pruritus,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “Together with VFMCRP, we are committed to bringing our first-of-its kind therapy to providers and patients around the world to help change the way pruritus is managed.”

"Chronic kidney disease-related itch is common for people on haemodialysis and represents a significant unmet need; leading to poor sleep and reduced quality of life for patients,” said Dr. Kieran McCafferty, Consultant Nephrologist, Barts Health NHS Trust. “We now have an option to help reduce the burden of CKD-related itch.”

MHRA approval and the NICE recommendation were 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.

About CSL Vifor

CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).