CARA - Cara Vifor's Kapruvia gets EMA panel backing to treat itch in hemodialysis patients

Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics (NASDAQ:CARA) said a committee of the European Medicines Agency’s (EMA) recommended the approval of Kapruvia (difelikefalin) to treat moderate-to-severe pruritus linked with chronic kidney disease in hemodialysis patients. The recommendation by the EMA's Committee for Medicinal Products for Human Use was backed by data from two phase-3 trials, KALM-1 and KALM-2, and supportive data from additional 32 clinical studies. The European Commission decision on the application is expected in Q2. Kapruvia is approved in the U.S. under the name KORSUVA (difelikefalin) injection. CARA +1.97% premarket to $10.35

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Cara, Vifor's Kapruvia gets EMA panel backing to treat itch in hemodialysis patients