EU approves Kapruvia in pruritus associated with chronic kidney disease in hemodialysis patients
Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics announced that the European Commission has granted marketing authorization to Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adult hemodialysis patients.
The marketing authorization, which approves Kapruvia for use in all member states of the European Union plus Iceland, Liechtenstein and Norway, follows the FDA approval of Korsuva (difelikefalin) injection in August 2021 for the same indication. Kapruvia will be the first therapy available in Europe for the treatment of CKD-associated pruritus in hemodialysis patients.
The approval in Europe is based on pivotal clinical data from two phase-III trials, KALM-1 and KALM-2, as well as supportive data from an additional 32 clinical studies. These studies showed that treatment with Kapruvia resulted in clinically meaningful improvements in pruritus severity and in pruritus-related quality of life components and was found to be generally well tolerated in patients with moderate-to-severe CKD-associated pruritus.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.