By Chris Wack

 

Cara Therapeutics Inc. shares were up 7% to $15.20 after the company said the U.S. Food and Drug Administration has approved Korsuva difelikefalin for injection in the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis.

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

The company said the Korsuva injection New Drug Application 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.

Cara Therapeutics said it expects to work with partner Vifor Pharma to launch Korsuva injection in the U.S. in the coming months.

This approval is based on the New Drug Application filing that was supported by positive data from two pivotal phase-III trials. Korsuva injection was found to be generally well tolerated.

Vifor Pharma and Cara have agreed to an exclusive license to commercialize Korsuva injection in the U.S. That agreement features a Cara 60%, Vifor Pharma 40% profit-sharing arrangement in non-Fresenius Medical Care clinics in the U.S.

Vifor Pharma and Cara Therapeutics are in the process of submitting the required documentation to the U.S. Centers for Medicare and Medicaid Services to ensure reimbursement and patient access to the Korsuva injection. Vifor Pharma expects to begin to marketing Korsuva in the first quarter of 2022, with reimbursement expected in the first half.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

August 24, 2021 10:38 ET (14:38 GMT)

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