FDA approves Korsuva as treatment for pruritus in patients on hemodialysis
Vifor Pharma and Cara Therapeutics announced the FDA has approved Korsuva for the treatment of moderate to severe pruritus in patients on hemodialysis.
Korsuva (difelikefalin) is an injectable kappa opioid receptor agonist that targets the body’s peripheral nervous system, the companies said in a joint press release.
“We are very excited about the FDA approval of Korsuva injection,” Abbas Hussain, CEO of Vifor Pharma, said in the release. “We are committed to bringing this first-in-class medicine to U.S. hemodialysis patients as fast as possible, together with our partner Cara Therapeutics.”
The FDA reviewed data from two phase 3 trials – KALM-1, conducted in the U.S., and the global KALM-2 – as well as supportive data from an additional 32 clinical studies, according to the release. Korsuva injection was found to be generally well tolerated, the companies said.
“Participating in the robust clinical trial program, we have learned that Korsuva injection represents an effective treatment option,” Frank Maddux, MD, global chief medical officer of Fresenius Medical Care, said. “We have seen substantial improvement in symptoms and meaningful relief for people suffering from severe and debilitating itch.”
The companies said they are in the process of submitting the required documentation to CMS to ensure timely reimbursement and patient access to the drug. Vifor Pharma said it expects to begin marketing Korsuva in the first quarter of 2022.