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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

Aug 23, 2021Approval  FDA Approves Korsuva (difelikefalin) Injection for the Treatment of Moderate-to-Severe Pruritus in Hemodialysis Patients
Apr 29, 2021Cara Therapeutics Announces Topline Results From KARE Phase 2 Dose-Ranging Trial of Oral Korsuva in Atopic Dermatitis Patients with Moderate-to-Severe Pruritus
Mar  8, 2021Vifor Pharma and Cara Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for Korsuva Injection in Hemodialysis Patients With Moderate-to-Severe Pruritus
Jan 11, 2021Cara Initiates Phase 2 Trial of Oral Korsuva for the Treatment of Pruritus in Patients with Notalgia Paresthetica
Dec 28, 2020Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Korsuva Injection in Hemodialysis Patients with Moderate-to-Severe Pruritus
Apr 21, 2020Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma Announce Positive Results From Global KALM-2 Pivotal Phase 3 Trial of Korsuva Injection in Hemodialysis Patients with Pruritus
Nov 11, 2019Cara Therapeutics Announces Publication of Difelikefalin (Korsuva Injection) KALM-1 Phase 3 Trial Results in the New England Journal of Medicine
Aug  7, 2018Cara Therapeutics Doses First Patient in Second Pivotal Phase 3 Efficacy Trial of Korsuva (CR845/difelikefalin) Injection in Hemodialysis Patients with Chronic Kidney Disease-Associated Pruritus

Further information

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