Cara, Vifor receive FDA nod for Korsuva

Cara Therapeutics and Vifor Pharma have obtained the Food and Drug Administration’s clearance for Korsuva (difelikefali) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis .

The medication is a first-in-class kappa opioid receptor agonist that targets the body’s peripheral nervous system.

“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, Cara president and CEO.

“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.”

“We are very excited about the FDA approval of Korsuva injection,” said Abbas Hussain, CEO 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.”