Cara Therapeutics Shares Rise 7% on FDA Approval of Korsuva Injection
August 24 2021 - 10:46AM
Dow Jones News
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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