BRIEF—Kapruvia approved by EC for pruritus in hemodialysis patients

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 from Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics.

The marketing authorization, which approves Kapruvia for use in all member states of the European Union plus Iceland, Liechtenstein and Norway, follows the US Food and Drug Administration 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.

“We are very excited about the European Commission’s approval of Kapruvia, marking an important milestone on our journey to advance and fundamentally change the treatment paradigm for people living with the severe burden of pruritus associated with chronic kidney disease,” said Dr Klaus Henning Jensen, chief medical officer of Vifor Pharma.

“We look forward to bringing this first-in-class therapy to patients in Europe, with launch in first markets expected in the second half of 2022,” he added.