Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics have announced the receipt of marketing authorisation from European Commission for Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritus linked with chronic kidney disease (CKD) in adult hemodialysis patients.
This marketing authorisation is applicable for use of Kapruvia in all member states of the European Union besides Iceland, Liechtenstein and Norway.
The approval comes after the US Food and Drug Administration (FDA) approval of KORSUVA (difelikefalin) injection in August 2021 for the same indication.
Kapruvia is claimed to be the first therapy available in Europe to treat CKD-associated pruritus in hemodialysis patients.
Vifor Pharma chief medical officer Dr. Klaus Henning Jensen said: “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.
“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.”
Cara Therapeutics chief medical officer Dr. Joana Goncalves said: “The European Commission’s approval of Kapruvia provides a much-needed therapy to hemodialysis patients in Europe who suffer from pruritus.
“We are excited to bring an innovative drug to physicians to help change the way pruritus is managed. We continue to work with our commercial partner VFMCRP, to fill a significant unmet medical need among CKD patients with pruritus in both the U.S. and Europe.”
The EC gave approval based on clinical data from two phase-III trials, KALM-1 and KALM-2, as well as supportive data from a further 32 clinical studies.
These studies indicated that treatment with Kapruvia led to ‘clinically meaningful’ improvements in pruritus severity and in pruritus-associated quality of life components.
It was found to be generally well tolerated in patients suffering with moderate-to-severe CKD-associated pruritus.