First and only therapy approved by the FDA for the treatment of pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis
Promotional launch of KORSUVA™ injection in the U.S. is expected in Q1 2022, with reimbursement in H1 2022

ZURICH, SWITZERLAND-- August 24, 2021 -- Regulatory News:

Vifor Pharma and Cara Therapeutics (Nasdaq:CARA) today 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) agonist 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 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.”

“We are pleased to see that KORSUVA™ injection has received FDA approval as the first treatment option approved for moderate to severe pruritus in adult CKD patients on hemodialysis,” commented Dr. Frank Maddux, Global Chief Medical Officer of Fresenius Medical Care. “Participating in the robust clinical trial program we have learned that KORSUVA™ injection represents an effective treatment option. We have seen substantial improvement in symptoms and meaningful relief for people suffering from severe and debilitating itch.”

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 and Cara have agreed to an exclusive license to commercialize KORSUVA™ injection in the United States. That agreement features a Cara 60%, Vifor Pharma 40% profit-sharing arrangement in non-Fresenius Medical Care clinics in the U.S. Under a previous agreement, Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics have agreed to market KORSUVA™ injection to Fresenius Medical Care North America dialysis clinics in the U.S. under a Cara 50%, Vifor Pharma 50% profit-sharing arrangement.

Vifor Pharma and Cara Therapeutics are in the process of submitting the required documentation to the U.S. Centers for Medicare and Medicaid Services (CMS) to ensure timely reimbursement and patient access to KORSUVA™ injection. Vifor Pharma expects to begin to market KORSUVA™ injection in Q1 2022 with reimbursement expected in H1 2022, subject to CMS timelines.