The U.S. Food and Drug Administration has approved Korsuva or difelikefalin for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis, Vifor Pharma and Cara Therapeutics (CARA) said in a statement on Tuesday.
Vifor Pharma expects to begin to market Korsuva injection in the first-quarter of 2022 with reimbursement expected in the first-half of 2022.
Korsuva injection is a first-in-class kappa opioid receptor agonist that targets the body's peripheral nervous system.
The companies have agreed to an exclusive license to commercialize Korsuva injection in the United States. The agreement features a Cara 60%, Vifor Pharma 40% profit-sharing arrangement in non-Fresenius Medical Care clinics in the U.S.
As per a previous deal, 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.
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