【Medical Companion Travel】KORSUVA injection in Japan to treat pruritus in hemodialysis patients achieved positive results

Introduction: Systemic pruritus refers to a skin disease that is clinically free of primary skin lesions and is dominated by pruritus, often as a concomitant or first symptom of many systemic diseases, recently, Cara Pharmaceutical Company announced the results of the study of KORSUVA injection, which is used to treat pruritus in hemodialysis patients.

On January 10, 2022, Cara Biopharma announced that kolsuva (difelikefalin) injection for the treatment of pruritus in hemodialysis patients had reached the primary endpoint of the trial in a japanese double-blind, placebo-controlled Phase 3 clinical study.

KORSUVA is a kappa opioid receptor agonist developed in the Cara lab for the treatment of itching caused by moderate to severe chronic kidney disease (CKD-aP) in adults receiving hemodialysis (HD).

KORSUVA injection is used to treat CKD-aP in hemodialysis patients, and the FDA has granted the drug breakthrough therapy designation and the application for the drug has been prioritized.

In the Phase 3 study, 178 patients received 6 weeks of dietlike falin or placebo, followed by a 52-week extended period of dietlikefalin. The primary endpoints (changes in pruritus numerical scale scores) and secondary endpoints (changes in pruritus scores in the Shiratori severity criteria) in the difelikefalin group improved significantly from baseline compared to the placebo group.

Difelikefalin is well tolerated. The most common adverse reactions (incidence ≥2%) were diarrhea (9.0%), dizziness (6.8%), nausea (6.6%), gait disturbance (6.6%), hyperkalemia (4.7%), headache (4.5%), drowsiness (4.2%), and altered mental status (3.3%).

Christopher Posner, President and CEO of Cara, said: "We are pleased that our partner has announced the positive results of its Phase 3 study in Japan evaluating dietlike falin for the treatment of pruritus in hemodialysis patients. This marks another important step forward in bringing first-class treatments to pruritus patients worldwide. ”

KORSUVA injection was approved by the FDA in August 2021 for the treatment of moderate to severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. Cara's U.S. business partner, Vifor Pharmaceuticals, is scheduled to launch KORSUVA injection in the U.S. early in the second quarter of 2022. In addition, the market authorization application for difelikefalin injection for the treatment of chronic kidney disease-related pruritus in hemodialysis patients is under review by the European Medicines Agency.