Cara Therapeutics (Nasdaq: CARA) and Vifor Pharma today
announced that the U.S. Food and Drug Administration (FDA) has
approved KORSUVA™ (difelikefalin) for injection for 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 (KOR) agonist that targets the
body’s peripheral nervous system. The KORSUVA™ injection new drug
application (NDA) 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.
“The FDA approval of KORSUVA™ injection is a transformational
milestone for Cara and a significant advancement for the
substantial number of adult hemodialysis patients suffering from
moderate-to-severe pruritus,” said Derek Chalmers, Ph.D., D.Sc.,
President and Chief Executive Officer of Cara Therapeutics. “We
look forward to working closely with our commercial partner, Vifor
Pharma, to launch KORSUVA™ injection in the U.S in the coming
months. We extend our deepest gratitude to the patients who
participated in our KALM-1 and KALM-2 clinical trials, the study
investigators, and especially our employees, as their commitment
through over 10 years of collective effort made this important
milestone possible.”
“We are very excited about the FDA approval of KORSUVA™
injection,” said Abbas Hussain, Chief Executive Officer of Vifor
Pharma “There is a significant unmet medical need for a targeted
therapy, and we believe that KORSUVA™ injection can fundamentally
change the treatment paradigm for adult CKD-aP patients undergoing
dialysis. We are committed to bringing this first-in-class medicine
to U.S. hemodialysis patients as fast as possible, together with
our partner Cara Therapeutics.”
“We are pleased to see that KORSUVA™ injection has received FDA
approval as the first treatment option approved for moderate to
severe pruritus in adult CKD patients on hemodialysis”, commented
Dr. Frank Maddux, Global Chief Medical Officer of Fresenius Medical
Care, “Participating in the robust clinical trial program we have
learned that KORSUVA™ injection represents an effective treatment
option. We have seen substantial improvement in symptoms and
meaningful relief for people suffering from severe and debilitating
itch.”
This approval is based on the New Drug Application filing that
was 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.KORSUVA™ injection was
found to be generally well tolerated.
Vifor Pharma and Cara have agreed to an exclusive license to
commercialize KORSUVA™ in the United States. That agreement
features a Cara 60%, Vifor Pharma 40% profit-sharing arrangement in
non-Fresenius Medical Care clinics in the U.S. Under a previous
agreement, Vifor Fresenius Medical Care Renal Pharma and Cara
Therapeutics have agreed to market KORSUVA™ injection to Fresenius
Medical Care North America dialysis clinics in the U.S. under a
Cara 50%, Vifor Pharma 50% profit-sharing arrangement.
Vifor Pharma and Cara Therapeutics are in the process of
submitting the required documentation to the U.S. Centers for
Medicare and Medicaid Services (CMS) to ensure timely reimbursement
and patient access to KORSUVA™ injection. Vifor Pharma expects to
begin promoting KORSUVA™ Injection in Q1 2022 with reimbursement
expected in H1 2022, subject to CMS timelines.
Conference Call
Cara management will host a conference call today at 5:00 p.m.
ET to discuss the approval of KORSUVA injection for the treatment
of moderate-to-severe pruritus in hemodialysis patients.
To participate in the conference call, please dial (855)
445-2816 (domestic) or (484) 756-4300 (international) and refer to
conference ID 1485906. A live webcast of the call can be accessed
under "Events & Presentations" in the News & Investors
section of the Company's website at www.CaraTherapeutics.com.
An archived webcast recording will be available on the Cara
website beginning approximately two hours after the call.
Contacts and further information:
Media ContactClaire LaCagnina 6
Degrees 315-765-1462 clacagnina@6degreespr.com |
Investor ContactJanhavi MohiteStern Investor
Relations, Inc.212-363-1200janhavi.mohite@sternir.com |
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Vifor Pharma contacts:Media RelationsNathalie
PonnierGlobal Head Corporate Communications+41 79 957 96 73
media@viforpharma.com |
Investor RelationsJulien Vignot Head of Investor
Relations+41 58 851 66 90investors@viforpharma.com |
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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 completed Phase 2 trials for the
treatment of pruritus in patients with CKD and atopic dermatitis
and is currently in Phase 2 trials in 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
About KORSUVA™ InjectionKORSUVA is a kappa
opioid receptor agonist developed in Cara laboratories and
indicated for the treatment of moderate-to-severe pruritus
associated with chronic kidney disease (CKD-aP) in adults
undergoing hemodialysis (HD). KORSUVA Injection is not a federally
controlled substance.
Breakthrough Therapy Designation was received from the FDA for
KORSUVA Injection for the treatment of CKD-aP in HD patients and
the New Drug Application was evaluated by the FDA with Priority
Review.
Important Safety Information
Warnings and PrecautionsDizziness, Somnolence,
Mental Status Changes, and Gait Disturbances: These adverse
reactions, including falls, have occurred in patients taking
KORSUVA and may subside with continued treatment. Concomitant use
of centrally acting depressant medications, sedating
antihistamines, and opioid analgesics may increase the likelihood
of these adverse reactions and should be used with caution during
treatment with KORSUVA.
Risk of Driving and Operating Machinery: Dizziness, somnolence,
and mental status changes have occurred in patients taking KORSUVA.
KORSUVA may impair the mental or physical abilities needed to
perform potentially hazardous activities such as driving a car and
operating machinery. Advise patients not to drive or operate
dangerous machinery until the effect of KORSUVA on their ability to
do so is known.
Adverse ReactionsThe most common adverse
reactions (incidence ≥2% and ≥1% higher than placebo) were diarrhea
(9.0%), dizziness (6.8%), nausea (6.6%), gait disturbances,
including falls (6.6%), hyperkalemia (4.7%), headache (4.5%),
somnolence (4.2%), and mental status changes (3.3%).
Use in Specific PopulationsSevere Hepatic
Impairment: The influence of severe hepatic impairment on the
pharmacokinetics of KORSUVA in subjects undergoing hemodialysis
(HD) has not been evaluated; therefore, use of KORSUVA in this
population is not recommended. Geriatric Use: The incidence of
somnolence was higher in KORSUVA-treated subjects aged 65 years and
older (7.0%) than in KORSUVA-treated subjects less than 65 years of
age (2.8%). The incidence was comparable in both placebo age groups
(3.0% and 2.1%, respectively).
IndicationKORSUVA is indicated for the
treatment of moderate to severe pruritus associated with chronic
kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).
Limitation of Use: KORSUVA has not been studied in patients on
peritoneal dialysis and is not recommended for use in this
population.
Please see KORSUVA™ injection full Prescribing
Information at www.korsuva.com.
About Chronic Kidney Disease-associated
PruritusCKD-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.
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 timeline for launch of KORSUVA™ injection, the potential
timeline for reimbursement and the potential of KORSUVA™ 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.
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.
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