Vifor Pharma and Cara Therapeutics’ Korsuva injection has been approved by the US Food and Drug Administration (FDA) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in haemodialysis patients.

The jab, which is a kappa opioid receptor (KOR) agonist that targets the body’s peripheral nervous system, was granted a priority review in March 2021. Korsuva will be commercialised globally by Vifor Pharma.

The new drug application (NDA) filing was supported by positive data from two pivotal phase-III trials KALM-1, conducted in the US and the global KALM-2, as well as supportive data from an additional 32 clinical studies.

“Participating in the robust clinical trial programme we have learned that Korsuva injection represents an effective treatment option. We have seen substantial improvement in symptoms and meaningful relief for people suffering from severe and debilitating itch,”said Frank Maddux, global chief medical officer of Fresenius Medical Care.

“We are very excited about the FDA approval of Korsuva injection.T here is a significant unmet medical need for a targeted therapy, and we believe that Korsuva injection can fundamentally change the treatment paradigm for adult CKD-aP patients undergoing dialysis. We are committed to bringing this first-in-class medicine to US haemodialysis patients as fast as possible, together with our partner Cara Therapeutics,” said Vifor Pharma CEO Abbas Hussain.

Promotional launch of Korsuva injection in the US is expected in Q1 2022, with reimbursement expected in the first half of 2022.