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Vifor Pharma and Cara Therapeutics announce U.S. FDA approval of KORSUVA™ injection for the treatment of moderate-to-severe pruritus in hemodialysis patients
AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR First and only therapy approved by the FDA for the treatment of pruritus associated with chronic kidney disease
About this update from Tvardi Therapeutics, Inc.
[{"type":"text","content":"\nAD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR\n\n\nFirst and only therapy approved by the FDA for the treatment of pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis \n\n\nPromotional launch of KORSUVA™ injection in the U.S. is expected in Q1 2022, with reimbursement in H1 2022\n\n\n ST. GALLEN, Switzerland & STAMFORD, Conn.--(BUSINESS WIRE)--\nRegulatory News:\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210823005635/en/\nVifor 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.\n\n“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.”\n\n“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 co...