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Cara Therapeutics and Vifor Pharma announce U.S. FDA approval of KORSUVA™ (difelikefalin) injection for the treatment of moderate-to-severe pruritus in hemodialysis patients
First and only therapy approved by the FDA for the treatment of pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis
About this update from Tvardi Therapeutics, Inc.
[{"type":"text","content":"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 2022Company to host conference call today at 5.00 p.m. ET STAMFORD, Conn. and ST. GALLEN, Switzerland, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Cara Therapeutics (Nasdaq: CARA) and Vifor Pharma 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. “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 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.” “We are pleased to see that KORSUVA™ injection has...