FDA approval of Korsuva injection

Korsuva injection is a first-in-class kappa opioid receptor (KOR) agonist that targets the body’s peripheral nervous system.

The Korsuva injection new drug application (NDA) received Priority Review by the FDA, which 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.

This approval is based on the New Drug Application filing that was supported by positive data from two pivotal Phase III trials – KALM-1, conducted in the U.S. (New England Journal of Medicine 2020; 382:222-232), and the global KALM-2, as well as supportive data from an additional 32 clinical studies. Korsuva injection was found to be generally well tolerated.

Vifor Pharma and Cara have agreed to an exclusive license to commercialize Korsuva in the United States. That agreement features a Cara 60%, Vifor Pharma 40% profit-sharing arrangement in non-Fresenius Medical Care clinics in the U.S. Under a previous agreement, Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics have agreed to market Korsuva injection to Fresenius Medical Care North America dialysis clinics in the U.S. under a Cara 50%, Vifor Pharma 50% profit-sharing arrangement.