FDA approves Korsuva for pruritus associated with CKD
The U.S. Food and Drug Administration (FDA) has approved KORSUVA (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.
Korsuva is supplied as a single-dose vial containing 65mcg/1.3mL of difelikefalin as a sterile, preservative-free solution for intravenous injection. Korsuva has not been studied in patients on peritoneal dialysis and is not recommended in this population as well as in those with severe hepatic impairment.
This approval is based on the New Drug Application filing that was 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. KORSUVA™ injection was found to be generally well tolerated.
The primary efficacy endpoint for both studies was the proportion of patients with an improvement of at least 4 points from baseline at week 12 in the weekly mean score on the 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS).
KORSUVA™ injection is a first-in-class kappa opioid receptor (KOR) agonist that targets the body's peripheral nervous system and indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). KORSUVA injection is not a federally controlled substance.
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.
"We are very excited about the FDA approval of KORSUVA™ injection," said Abbas Hussain, Chief Executive Officer of Vifor Pharma. "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. We are committed to bringing this first-in-class medicine to U.S. hemodialysis patients as fast as possible, together with our partner Cara Therapeutics."
"The FDA approval of KORSUVA™ injection is a transformational milestone for Cara and a significant advancement for the substantial number of adult hemodialysis patients suffering from moderate-to-severe pruritus," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "We look forward to working closely with our commercial partner, Vifor Pharma, to launch KORSUVA™ injection in the U.S. in the coming months. 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."
KORSUVA is expected to be available in the US in the first quarter of 2022.
