Korsuva FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 25, 2021.
FDA Approved: Yes (First approved August 23, 2021)
Brand name: Korsuva
Generic name: difelikefalin
Dosage form: Injection
Company: Cara Therapeutics, Inc.
Treatment for: Chronic Kidney Disease-Associated Pruritus
Korsuva (difelikefalin) is a selective peripheral kappa opioid receptor agonist indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).
- Chronic Kidney Disease-associated Pruritus (CKD-aP) is a debilitating systemic itch condition that affects a large number dialysis patients. It is thought to be caused by immune system dysfunction, build-up of toxins, metabolic abnormalities and an imbalance in opiate receptors including antagonism of peripheral kappa-opioid receptors.
- Korsuva works to alleviate pruritus by selectively targeting peripheral kappa-opioid receptors.
- The Korsuva approval was supported by positive data from the KALM-1 and KALM-2 clinical trials.
- Korsuva is administered via intravenous bolus injection into the venous line of the dialysis circuit at the end of each hemodialysis treatment.
- Common adverse reactions include diarrhea, dizziness, nausea, gait disturbances, including falls, hyperkalemia, headache, somnolence, and mental status change.
Development timeline for Korsuva
Further information
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