Cara Therapeutics and Vifor Pharma announce U.S. FDA acceptance and Priority Review of NDA for KORSUVA™* injection in hemod...
March 08 2021 - 1:00AM
Cara Therapeutics (Nasdaq:CARA) and Vifor Pharma today
announced that the U.S. Food and Drug Administration (FDA) has
accepted and granted Priority Review for the New Drug Application
(NDA) for KORSUVA™ (difelikefalin) solution for injection for the
treatment of moderate-to-severe pruritus in hemodialysis patients.
The PDUFA target action date for KORSUVA is August 23, 2021. The
FDA stated that currently it is not planning to hold an advisory
committee meeting to discuss the application.
The FDA grants Priority Review to drug applications for
potential therapies that, if approved, would be significant
improvements in the safety or effectiveness of the treatment,
diagnosis, or prevention of serious conditions when compared to
standard applications. The NDA filing is supported by positive data
from two pivotal Phase 3 trials – KALM-1, conducted in the U.S.
(New England Journal of Medicine 2020; 382:222-232), and the global
KALM-2, as well as supportive data from an additional 32 clinical
studies.
“The FDA acceptance for filing and granting of Priority Review
for the KORSUVA NDA marks a significant milestone for Cara and for
the substantial number of hemodialysis patients with chronic
intractable pruritus,” said Derek Chalmers, Ph.D., D.Sc., President
and Chief Executive Officer of Cara Therapeutics. “The FDA’s
agreement to expedite the timeline through Priority Review
designation aligns with our understanding of the therapeutic
potential of KORSUVA to fundamentally change the treatment paradigm
for this serious unmet need. We look forward to working with the
FDA through the review process and, along with our commercial
partner, Vifor Pharma, remain focused on preparing for the U.S.
launch of KORSUVA injection, if approved.”
“We are delighted that the FDA accepted and granted Priority
Review for this breakthrough therapy. Pruritus in hemodialysis
patients is a debilitating condition with a significant impact on
quality of life and increased risk for hospitalization and
mortality. It impacts up to 40% of dialysis patients around the
world. If KORSUVA is approved, we will be able to offer a medicine
that is in line with our aim to deliver innovative therapies to
patients with high unmet medical needs. We are highly committed to
bringing this important new treatment to patients in the U.S. as
soon as possible following FDA approval, together with our partner
Cara Therapeutics,” commented Stefan Schulze, CEO of Vifor Pharma
Group.
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.1,2,3 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.4 CKD-aP is also an independent predictor of
mortality among hemodialysis patients, mainly related to increased
risk of inflammation and infections.
References:1 Pisoni RL, et al. Pruritus in haemodialysis
patients: international results from the Dialysis Outcomes and
Practice Patterns Study. Nephrol Dial Transplant. 2006;
21:3495-3505.2 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: 1-12.3 Sukul et al.
Self-reported Pruritus and Clinical, Dialysis-Related, and
Patient-Reported Outcomes in Hemodialysis Patients. Kidney Med.
2020 Nov 21;3(1):42-53.4 Mathur VS, et al. A longitudinal
study of Uremic Pruritus in hemodialysis patients. Clin J Am
Soc Nephrol. 2010; 5(8):1410-1419.
* 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.
Contacts and
further information: |
|
Media
ContactClaire LaCagnina6
Degrees315-765-1462clacagnina@6degreespr.com |
Investor
ContactJanhavi MohiteStern Investor Relations,
Inc.212-363-1200janhavi.mohite@sternir.com |
|
|
Vifor Pharma Group
Contacts |
|
|
|
Media
RelationsNathalie PonnierGlobal Head Corporate
Communications+41 79 957 96 73 media@viforpharma.com |
Investor
RelationsJulien VignotHead of Investor Relations+41 58 851
66 90investors@viforpharma.com |
About Cara TherapeuticsCara 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, primary biliary cholangitis
and notalgia paresthetica patients with moderate-to-severe
pruritus.
About Vifor Pharma GroupVifor Pharma Group is a
global pharmaceuticals company. It aims to become the global leader
in iron deficiency, nephrology and cardio-renal therapies. The
company is a partner of choice for pharmaceuticals and innovative
patient-focused solutions. Vifor Pharma Group strives to help
patients around the world with severe and chronic diseases lead
better, healthier lives. The company develops, manufactures and
markets pharmaceutical products for precision patient care. Vifor
Pharma Group holds a leading position in all its core business
activities and consists of the following companies: Vifor Pharma
and Vifor Fresenius Medical Care Renal Pharma (a joint company with
Fresenius Medical Care). Vifor Pharma Group is headquartered in
Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss
Exchange, VIFN, ISIN: CH0364749348). For more information, please
visit viforpharma.com.
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™ solution for injection
and the potential timeline for FDA review of the NDA and the
potential of KORSUVA™ solution for injection to be a therapeutic
option for CKD-aP in dialysis dependent patients. 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 Annual Report on
Form 10-K for the year ended 31 December 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
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