Cara Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for KORSUVA™ Injection in Hemodialysis ...
December 28 2020 - 7:00AM
Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company
focused on developing and commercializing new chemical entities
designed to alleviate pruritus by selectively targeting peripheral
kappa opioid receptors, or KORs, today announced that it has
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for KORSUVA™ Injection (difelikefalin) for the
treatment of moderate-to-severe pruritus in hemodialysis patients.
KORSUVA Injection received Breakthrough Therapy Designation from
the FDA for this indication. Cara has requested Priority Review for
the NDA which, if granted, could result in a six-month review
process. The FDA has a 60-day filing review period to determine
whether the NDA is complete and acceptable for filing.
The NDA submission is supported by positive data
from two pivotal Phase 3 trials of KORSUVA Injection, including the
KALM-1 trial conducted in the U.S. (New England Journal of Medicine
2020; 382:222-232) and the global KALM-2 trial, as well as
supportive data from an additional 32 clinical studies.
“The NDA submission for KORSUVA Injection marks
a significant milestone for Cara and for hemodialysis patients who
suffer from intractable pruritus,” said Derek Chalmers, Ph.D.,
D.Sc., President and Chief Executive Officer of Cara Therapeutics.
“I’d like to thank the entire Cara team for working tirelessly to
bring this first-in-class therapeutic from in-house discovery,
through development to the completion of NDA submission, as well as
the patients, investigators and site personnel who participated in
the clinical trials. We look forward to working with the FDA
through the review process and, along with our commercial partner,
Vifor Pharma, remain focused on preparation for the U.S. launch of
KORSUVA Injection, if approved.”
About Chronic Kidney Disease-Associated
Pruritus (CKD-aP)
CKD-aP is an intractable systemic itch condition
that occurs with high frequency and intensity in patients with
chronic kidney disease undergoing dialysis. Pruritus has also
been reported in patients with stage III-V CKD who are not on
dialysis. Aggregate, longitudinal, multi-country studies
estimate the weighted prevalence of CKD-aP to be approximately 40%
in patients with end-stage renal disease (ESRD), with approximately
25% of patients reporting severe pruritus. The majority of
dialysis patients (approximately 60 to 70%) report pruritus, with
30 to 40% reporting moderate or severe pruritus.1,2 Recent
data from the ITCH National Registry Study showed that among those
with pruritus, approximately 59% experienced symptoms daily or
nearly daily for more than a year. Given its association with
CKD/ESRD, most afflicted patients will continue to have symptoms
for months or years, with currently employed antipruritic
treatments, such as antihistamines and corticosteroids, unable to
provide consistent, adequate relief. Moderate-to-severe chronic
pruritus has repeatedly been shown to directly decrease quality of
life, contribute to symptoms that impair quality of life (such as
poor sleep quality), and is associated with
depression.3 CKD-aP is also an independent predictor of
mortality among hemodialysis patients, mainly related to increased
risk of inflammation and infections.
References:
- Pisoni RL, et al. Pruritus in
hemodialysis patients: international results from the Dialysis
Outcomes and Practice Patterns Study. Nephrol Dial
Transplant. 2006; 21:3495-3505.
- Ramakrishnan K, et
al. Clinical characteristics and outcomes of end-stage renal
disease patients with self-reported pruritus
symptoms. International Journal of Nephrology and Renovascular
Disease. 2014; 7: 1-12.
- Mathur VS, et al. A
longitudinal study of Uremic Pruritus in hemodialysis
patients. Clin J Am Soc Nephrol. 2010;
5(8):1410-1419.
About Cara Therapeutics
Cara Therapeutics is a clinical-stage
biopharmaceutical company focused on developing and commercializing
new chemical entities designed to alleviate pruritus by selectively
targeting peripheral kappa opioid receptors, or KORs. Cara is
developing a novel and proprietary class of product candidates, led
by KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist
that targets the body’s peripheral nervous system, as well as
certain immune cells. In two Phase 3 trials, KORSUVA Injection has
demonstrated statistically significant reductions in itch intensity
and concomitant improvement in quality of life measures in
hemodialysis patients with moderate-to-severe chronic kidney
disease-associated pruritus (CKD-aP). Oral KORSUVA has successfully
completed a Phase 2 trial for the treatment of pruritus in patients
with CKD and is currently in Phase 2 trials in atopic dermatitis
and primary biliary cholangitis patients with moderate-to-severe
pruritus.
The FDA has conditionally accepted KORSUVA™ as
the trade name for difelikefalin injection. CR845/difelikefalin is
an investigational drug product and its safety and efficacy have
not been fully evaluated by any regulatory authority.
Forward-looking Statements
Statements contained in this press release
regarding matters that are not historical facts are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. Examples of these
forward-looking statements include statements concerning the
potential regulatory approval of KORSUVA Injection, the potential
for the receipt of Priority Review from the FDA, and the potential
timeline for FDA review of the NDA. Because such statements are
subject to risks and uncertainties, actual results may differ
materially from those expressed or implied by such forward-looking
statements. Risks are described more fully in Cara's filings with
the Securities and Exchange Commission, including the "Risk
Factors" section of Cara's Quarterly Report on Form 10-Q for the
quarter ended September 30, 2020 and its other documents
subsequently filed with or furnished to the Securities and
Exchange Commission. All forward-looking statements contained in
this press release speak only as of the date on which they were
made. Except to the extent required by law, Cara undertakes no
obligation to update such statements to reflect events that occur
or circumstances that exist after the date on which they were
made.
MEDIA CONTACT: Annie
Starr6 Degrees973-768-2170 astarr@6degreespr.com
INVESTOR CONTACT:Janhavi MohiteStern Investor
Relations, Inc.janhavi.mohite@SternIR.com
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