FDA Approves Difelikefalin for Chronic Kidney Disease-Associated Pruritus

Chronic kidney disease (CKD)-associated pruritus is a systemic itch condition occurring with a high frequency and intensity in patients with CKD undergoing dialysis.

Officials with the FDA have approved difelikefalin (Korsuva, Cara Therapeutics and Vifor Pharma) as an injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adults undergoing hemodialysis. The injection is a first-in-class kappa opioid receptor (KOR) agonist that targets the body’s peripheral nervous system, according to a press release from Cara Therapeutics and Vifor Pharma.

“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 Frank Maddux, MD, FACP, global chief medical officer of Fresenius Medical Care, in a press release. “Participating in the robust clinical trial program 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.”

CKD-associated pruritus (CKD-aP) is a systemic itch condition occurring with a high frequency and intensity in patients with CKD undergoing dialysis. It has also been reported in patients with stage 3-4 CKD who are not being treated through dialysis.

According to the investigators, approximately 60% to 70% of patients undergoing dialysis treatment experience pruritus, with 30% to 40% reporting moderate or severe pruritus. Moderate-to-severe chronic pruritus is associated with a decreased quality of life, symptoms that impair quality of life (such as poor sleep quality), and depression. CKD-aP also acts as an independent predictor of mortality among hemodialysis patients, mainly due to the associated risk of inflammation and infection.

“We are very excited about the FDA approval of Korsuva injection,” said Abbas Hussain, chief executive officer of Vifor Pharma, in the release. “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 CKD-aP patients undergoing dialysis.”

The approval is based on the results from a pair of phase 3 trials: KALM-1, conducted in the United States, and KALM-2, which was conducted globally. Supportive data were also sourced from 32 additional clinical studies.

REFERENCE

Cara Therapeutics and Vifor Pharma announce U.S. FDA approval of KORSUVA™ (difelikefalin) injection for the treatment of moderate-to-severe pruritus in hemodialysis patients [news release]. Globe Newswire; August 23, 2021. Accessed August 23, 2021. https://www.globenewswire.com/news-release/2021/08/23/2285085/0/en/Cara-Therapeutics-and-Vifor-Pharma-announce-U-S-FDA-approval-of-KORSUVA-difelikefalin-injection-for-the-treatment-of-moderate-to-severe-pruritus-in-hemodialysis-patients.html