Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics have announced that England’s National Institute for Health and Care Excellence (NICE) has recommended Kapruvia (difelikefalin) for the treatment of moderate-to-severe chronic kidney disease (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.
“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 Kieran McCafferty (Barts Health NHS Trust, London, UK). “We now have an option to help reduce the burden of CKD-related itch.”
“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 of global medical affairs at CSL Vifor. “We look forward to continue working with the National Health Service (NHS) to ensure access to this important medicine for patients as quickly as possible.”
MHRA approval and the NICE recommendation were supported by positive data from two pivotal phase-III trials – KALM-1, conducted in the USA, and the global KALM-2 trial, as well as supportive data from an additional 32 clinical studies, a press release states.
