The FDA has approved the use of the injectable drug KORSUVA in treating moderate to severe pruritus in adult patients undergoing hemodialysis for chronic kidney disease.
After approval of KORSUVA, the itching problem in CKD patients can be solved.
The U.S. Food and Drug Administration (FDA) has approved the use of the injectable drug KORSUVA (difelikefalin) in treating moderate to severe pruritus in adult patients undergoing hemodialysis for chronic kidney disease.
KORSUVA, the product of the collaboration between global pharmaceutical firms Vifor Pharma and Cara Therapeutics, is a first-in-class kappa opioid receptor (KOR) agonist that targets the body’s peripheral nervous system. It was found to have been successful in two pivotal Phase III trials: KALM-1, which was conducted in the U.S., and KALM-2, which had a global reach. An additional 32 clinical studies provided support, saying that the drug is generally well tolerated.
The FDA Approval of KORSUVA
KORSUVA recently received a Priority Review status for its New Drug Application (NDA), signifying that it could be a significant contributor in treating this serious condition. The U.S. FDA awards Priority Review to therapies that would offer substantial improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious illnesses when compared to standard applications.
“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 Cara Therapeutics president and chief executive officer Derek Chalmers, Ph.D., D.Sc., in a statement.
“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,” Chalmers added.
Vifor Pharma and Cara have an exclusive license to commercialize KORSUVA in the U.S. This deal gives Cara 60% and Vifor 40% in profit-sharing status in non-Fresenius Medical Care clinics in the country. Under a previous agreement, Vifor Fresenius Medical Care Renal Pharma and Cara agreed to market KORSUVA to Fresenius dialysis clinics in the U.S. under a 50-50 profit-sharing arrangement.
At present, Vifor and Cara are processing the documents that the U.S. Centers for Medicare and Medicaid Services had required to push forward with commercialization and distribution. Industry experts believe that KORSUVA will start being on the market in the first quarter of 2022, with reimbursement likely by the first half of the same year.
“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,” noted Vifor Pharma CEO Abbas Hussain in the same press release.
KORSUVA injection is not a federally controlled substance. Side effects can include dizziness, somnolence, and mental status changes. It is indicated for the CKD-aP patients who have moderate to severe pruritus on hemodialysis. It has yet to be tested on patients who are on peritoneal dialysis.
