30 March 2021 - Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics today announced that the EMA accepted to review the marketing authorisation application for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in haemodialysis patients.
The EMA filing is supported by positive clinical data from the two pivotal Phase 3 trials KALM-1 and KALM-2, as well as supportive data from an additional 32 clinical studies.