Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) have announced that the US’s National Institute for Health and Care Excellence (NICE) has recommended Kapruvia (difelikefalin) to treat chronic kidney disease (CKD)-associated pruritus.
Kapruvia has been recommenced to treat moderate-to-severe CKD-associated pruritus in adult patients who are undergoing haemodialysis.
This will allow patients in Northern Ireland, England, and Wales to get access to Kapruvia.
The recommendation from NICE follows the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) authorisation of Kapruvia for the same indication in April last year.
Cara Therapeutics president and CEO Christopher Posner said: “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.
“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.”
Kapruvia injection is claimed to be the first and only MHRA-approved treatment for moderate-to-severe (CKD)-associated pruritus.
The company stated that the NICE recommendation and MHRA authorisation were supported by findings obtained from KALM-1 and KALM-2 Phase III trials, along with supportive data from other 32 clinical trials.
Barts Health NHS Trust Nephrologist consultant Dr Kieran McCafferty said: “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.
“We now have an option to help reduce the burden of CKD-related itch.”