CARA - FDA accepts Cara Vifor's Korsuva application in pruritus due to hemodialysis

Under Priority review, the FDA has accepted Cara Therapeutics (CARA) and Vifor Pharma's (GNHAF) New Drug Application ((NDA)) for Korsuva (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients.The PDUFA target action date is August 23, 2021. The FDA is currently not planning to hold an advisory committee meeting to discuss the application.Priority Review shortens the review clock to six months from the standard 10 months. The NDA filing is supported by positive data from two phase-III trials KALM-1, conducted in the U.S. and the global KALM-2, as well as supportive data from an additional 32 clinical studies.

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FDA accepts Cara, Vifor's Korsuva application in pruritus due to hemodialysis