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Cara Therapeutics and Vifor Pharma announce U.S. FDA acceptance and Priority Review of NDA for KORSUVAa??* injection in hemodialysis patients with moderate-to-severe pruritus

FDA has set Prescription Drug User Fee Act (PDUFA) target action date of August 23, 2021




If approved, KORSUVAa?? injection would be first therapy for treatment of pruritus in hemodialysis patients

STAMFORD, Conn, and ST. GALLEN, Switzerland, March 08, 2021 (GLOBE NEWSWIRE) -- Cara Therapeutics (Nasdaq:CARA) and Vifor Pharma today announcedA that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVAa?? (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA is August 23, 2021. The FDA stated that currently it is not planning to hold an advisory committee meeting to discuss the application.The FDA grants Priority Review to drug applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The NDA filing is supported by positive data from two pivotal Phase 3 trials a?? 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.a??The FDA acceptance for filing and granting of Priority Review for the KORSUVA NDA marks a significant milestone for Cara and for the substantial number of hemodialysis patients with chronic intractable pruritus,a?? said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. a??The FDAa??s agreement to expedite the timeline through Priority Review designation aligns with our understanding of the therapeutic potential of KORSUVA to fundamentally change the treatment paradigm for this serious unmet need. We look forward to working with the FDA through the review process and, along with our commercial partner, Vifor Pharma, remain focused on preparing for the U.S. launch of KORSUVA injection, if approved.a??a??We are delighted that the FDA accepted and granted Priority Review for this breakthrough therapy. Pruritus in hemodialysis patients is a debilitating condition with a significant impact on quality of life and increased risk for hospitalization and mortality. It impacts up to 40% of dialysis patients around the world. If KORSUVA is approved, we will be able to offer a medicine that is in line with our aim to deliver innovative therapies to patients with high unmet medical needs. We are highly committed to bringing this important new treatment to patients in the U.S. as soon as possible following FDA approval, together with our partner Cara Therapeutics,a?? commented Stefan Schulze, CEO of Vifor Pharma Group.About Chronic Kidney Disease-associated Pruritus (CKD-aP)
CKD-aP is an intractable systemic itch condition that occurs with high frequency and intensity in patients with chronic kidney disease undergoing dialysis.A Pruritus has also been reported in patients with stage III-V CKD who are not on dialysis.A Aggregate, longitudinal, multi-country studies estimate the weighted prevalence of CKD-aP to be approximately 40% in patients with end-stage renal disease (ESRD), with approximately 25% of patients reporting severe pruritus.A The majority of dialysis patients (approximately 60 to 70%) report pruritus, with 30 to 40% reporting moderate or severe pruritus.1,2,3A Recent data from the ITCH National Registry Study showed that among those with pruritus, approximately 59% experienced symptoms daily or nearly daily for more than a year.A Given its association with CKD/ESRD, most afflicted patients will continue to have symptoms for months or years, with currently employed antipruritic treatments, such as antihistamines and corticosteroids, unable to provide consistent, adequate relief. Moderate-to-severe chronic pruritus has repeatedly been shown to directly decrease quality of life, contribute to symptoms that impair quality of life (such as poor sleep quality), and is associated with depression.4A CKD-aP is also an independent predictor of mortality among hemodialysis patients, mainly related to increased risk of inflammation and infections.
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