Vifor Pharma and Cara Therapeutics announced that 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 injection is a first-in-class kappa opioid receptor (KOR) that targets the body’s peripheral nervous system. The KORSUVA injection New Drug Application (NDA) received Priority Review by the FDA, which is granted to therapies that, if approved, would offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

“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 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.’’

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.

Vifor Pharma expects to begin to market KORSUVA injection in Q1 2022 with reimbursement expected in H1 2022, subject to CMS timelines.