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EX - 99.1 2 tm2125639d1_ex99-1.htm EXHIBIT 99.1 CCARA THERAPEUTICS Exhibit 99.1 VIFOR PHARMA Press Release 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 Promotional launch of KORSUVA ™ injection in the U.S. is expected in Q1 2022 , with reimbursement in H1 2022 Company to host conference call today at 5.00 p.m. ET Stamford , Conn . and St. Gallen , Switzerland , 23 August 2021 - 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 KORSUVAT 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 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 3 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 . 1/4