Korsuva injection achieves positive topline results in phase III clinical study in Japan for the treatment of pruritus in hemodialysis patients.
In the Phase III study, 178 patients were administered difelikefalin or placebo for 6 weeks followed by an open-label extension period of difelikefalin administration for 52 weeks. The primary endpoint, change in itch Numerical Rating Scale score, and the secondary endpoint, change in itching scores of Shiratori severity criteria, were significantly improved from baseline compared to the placebo group. Difelikefalin was well-tolerated.
Korsuva (difelikefalin) injection was approved by the FDA in August 2021 for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. Cara’s U.S. commercial partner Vifor Pharma is on track to launch Korsuva injection in the U.S. early in the second quarter of 2022. In addition, the Marketing Authorization Application for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients is undergoing review with the European Medicines Agency.
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