FDA approves KORSUVA™ Injection for the Treatment of Pruritus in Hemodialysis Patients

FDA approves KORSUVA™ Injection for the Treatment of Pruritus in Hemodialysis Patients

The Food and Drug Administration (FDA) recently approved a new therapeutic injection for the treatment of moderate-to-severe pruritis associated with chronic kidney disease in adults undergoing hemodialysis.

KORSUVA (difelikefalin) is a first-in-class kappa opioid receptor (KOR) that targets the body’s peripheral nervous system. It is the first and only FDA approved therapy for pruritis associated with chronic kidney disease (CKD).

“We are pleased to see that KORSUVA injection has received FDA approval as the first treatment option approved for moderate-to-severe pruritus in adult CKD patients on hemodialysis,” said Dr. Frank Maddux, Global Chief Medical Officer of Fresenius Medical Care. “Participating in the robust clinical trial program, we have learned that KORSUVATM injection represents an effective treatment option. We have seen substantial improvement in symptoms and meaningful relief for people suffering from severe debilitating itch.”

The KORSUVA™ injection New Drug Application (NDA) received Priority Review by the FDA. This review is granted to therapies that, if approved, would offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

The approval is based on the NDA filing that was supported by positive data from two critical phase-III trials conducted in the United States and globally. It is also supported by data from an additional 32 clinical studies in which found that KORSUVATM injection was generally well tolerated.

Pruritis is a condition that affects up to 60% of patients on hemodialysis and is associated with reduced quality of life and sleep, as well as depression. Other treatments and therapies have proved unable to provide consistent, adequate relief in the treatment of pruritis, but the KORSUVATM injection resulted in significant improvements in quality-of-life when compared to the placebo.

“We are very excited about the FDA approval of KORSUVATM injection,” said Abbas Hussain, Chief Executive Officer of Vifor Pharma. “There is a significant unmet medical need for a targeted therapy, and we believe that KORSUVA injection can fundamentally change the treatment paradigm for adult patients with chronic kidney disease-associated pruritus (CKD-aP) undergoing dialysis.”

Vifor Pharma and Cara Therapeutics announced that they are in the process of submitting the required documentation to the U.S Centers for Medicare and Medicaid Services (CMS) to ensure timely reimbursement and patient access to KORSURVA injection. Vifor Pharma said that it expects to begin to market KORSURVA injection in Q1 2022 with reimbursement expected in H1 2022, subject to CMS timelines.