CARA - EMA to review Cara Vifor's difelikefalin application for pruritus due to hemodialysis

Cara Therapeutics (CARA) and Vifor Fresenius Medical Care Renal Pharma (GNHAF) announce that the EMA has accepted to review the Marketing Authorization Application ((MAA)) for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients.The EMA will review the application under the centralized marketing authorization procedure. The EMA filing is supported by positive clinical data from the two phase-III trials KALM-1 and KALM-2, as well as from an additional 32 clinical studies.If approved, difelikefalin would receive marketing authorization in all member states of the EU, as well as in Iceland, Liechtenstein and Norway. EMA’s decision is expected in Q2-2022.Earlier this month, the FDA accepted Cara and Vifor's Korsuva application in pruritus due to kidney disease.

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EMA to review Cara, Vifor's difelikefalin application for pruritus due to hemodialysis