Korsuva injection filed in Japan for pruritus in hemodialysis patients
Cara Therapeutics announced that its licensing partner Maruishi Pharmaceutical Co., Ltd. submitted a New Drug Application (NDA) in Japan for approval of Korsuva (difelikefalin) for the treatment of pruritus in hemodialysis patients
The NDA includes positive results of a Phase III study in Japan, jointly conducted by Maruishi and its sublicensee Kissei Pharmaceutical Co., Ltd., in which 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.
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