CARA - Cara eyes 2H 2021 launch of Korsuva for pruritus in hemodialysis patients

Cara (NASDAQ:CARA) says following a potential FDA approval of Korsuva injection for chronic kidney disease-associated pruritus in hemodialysis later this month, it would launch the drug this half of the year. Korsuva (difelikefalin), which has Priority Review status, has an FDA action date of August 23. If approved, it would be the first treatment for the condition. Cara licensed Korsuva to Vifor (International) Ltd. (Vifor) in the U.S. for the pruritus indication under a Cara 60%, Vifor 40% profit-sharing arrangement. An application for difelikefalin is also pending before the European Medicines Agency. A decision is expected in Q2 2022. An oral version of Korsuva is also under development for atopic dermatitis ("AD"). Cara aims to begin a phase 3 trial in that indication by the end of the year, even though in April, top-line data show the drug missed its primary endpoint. In its Q2 2021 earnings today, Cara missed

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Cara eyes 2H 2021 launch of Korsuva for pruritus in hemodialysis patients