FDA approves Cara & Vifor’s drug for severe itching in kidney disease patients
pharmafile | August 24, 2021 | News story | Manufacturing and Production |
Vifor Pharma and Cara Therapeutics have gained FDA approval for Korsuva (difelikefalin) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing haemodialysis.
It became the first and only therapy approved by the FDA for the treatment of pruritus associated with chronic kidney disease (CKD-aP).
Korsuva injection is a kappa opioid receptor (KOR) agonist that targets the body’s peripheral nervous system.
Abbas Hussain, Chief Executive Officer of Vifor Pharma, said: “There is a significant unmet medical need for a targeted therapy, and we believe that Korsuva injection can fundamentally change the treatment paradigm for adult CKD-aP patients undergoing dialysis.”
The approval on Monday was based on the New Drug Application filing that was supported by positive data from two phase-III trials – KALM-1, conducted in the US and the global KALM-2, as well as supportive data from an additional 32 clinical studies. Korsuva injection was found to be generally well tolerated.
Vifor Pharma and Cara have agreed to an exclusive license to commercialise the injection in the US. That agreement features a Cara 60%, Vifor Pharma 40% profit-sharing arrangement in non-Fresenius Medical Care clinics in the US.
CKD-aP is an intractable systemic itch condition that occurs with high frequency and intensity in patients with chronic kidney disease undergoing dialysis. Pruritus has also been reported in patients with stage III-V CKD who are not on dialysis. Aggregate, longitudinal, multi-country studies estimate the weighted prevalence of CKD-aP to be approximately 40% in patients with end-stage renal disease, with approximately 25% of patients reporting severe pruritus. The majority of dialysis patients (approximately 60 to 70%) report pruritus, with 30 to 40% reporting moderate or severe pruritus.
Derek Chalmers, President and Chief Executive Officer of Cara Therapeutics, said: “The FDA approval of Korsuva injection is a transformational milestone for Cara and a significant advancement for the substantial number of adult haemodialysis patients suffering from moderate-to-severe pruritus.
“We extend our deepest gratitude to the patients who participated in our KALM-1 and KALM-2 clinical trials, the study investigators, and especially our employees, as their commitment through over 10 years of collective effort made this important milestone possible.”
Kat Jenkins
