Vifor Pharma & Cara Therapeutics announce U.S. FDA acceptance & Priority Review of NDA for KORSUVA™* injection in hemodialy...
March 08 2021 - 12:00AM
Business Wire
- FDA has set Prescription Drug User Fee Act (PDUFA) target
action date of 23 August 2021
- If approved, KORSUVA™ injection would be first therapy for
treatment of pruritus in hemodialysis patients
Regulatory News:
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Vifor Pharma and Cara Therapeutics, Inc. (Nasdaq: CARA) 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 23 August 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-III 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.
“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 US as soon
as possible following FDA approval, together with our partner Cara
Therapeutics”, commented Stefan Schulze, CEO of Vifor Pharma
Group.
“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. “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.”
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 in the US. CR845/difelikefalin is an
investigational drug product and its safety and efficacy have not
been fully evaluated by any regulatory authority.
About Vifor Pharma Group
Vifor 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
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-lII 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-II trial for the treatment of pruritus in patients with CKD
and is currently in phase-II trials in atopic dermatitis, primary
biliary cholangitis and notalgia paresthetica patients with
moderate-to-severe pruritus
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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Media Relations Nathalie Ponnier Global Head Corporate
Communications +41 79 957 96 73 media@viforpharma.com Investor
Relations Julien Vignot Head of Investor Relations +41 58 851
66 90 investors@viforpharma.com Cara Therapeutics contacts:
Media Contact Claire LaCagnina 6 Degrees 315-765-1462
clacagnina@6degreespr.com Investor Contact Janhavi Mohite
Stern Investor Relations, Inc. 212-363-1200
janhavi.mohite@sternir.com
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