Cara Therapeutics : EMA Accepts To Review MAA For Difelikefalin Injection

(RTTNews) - Cara Therapeutics Inc. (CARA) and Vifor Fresenius Medical Care Renal Pharma said that the European Medicines Agency or EMA accepted to review the Marketing Authorization Application or MAA for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients.

The filing was supported by positive clinical data from the two pivotal phase-III trials KALM-1 and KALM-2, as well as supportive data from an additional 32 clinical studies

If approved, difelikefalin would receive marketing authorization in all member states of the European Union, as well as in Iceland, Liechtenstein and Norway. EMA's decision on the EU MAA is expected in the second-quarter of 2022.