AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR
- First and only therapy approved by the FDA for the treatment
of pruritus associated with chronic kidney disease (CKD-aP) in
adults undergoing hemodialysis
- Promotional launch of KORSUVA™ injection in the U.S. is
expected in Q1 2022, with reimbursement in H1 2022
Regulatory News:
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Vifor Pharma and Cara Therapeutics (Nasdaq:CARA) 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.
“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.”
“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 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-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. 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 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 to market KORSUVA™ injection in Q1 2022 with reimbursement
expected in H1 2022, subject to CMS timelines.
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 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 AD and is currently
in Phase 2 trials in PBC and NP patients with moderate-to-severe
pruritus.
About KORSUVA™ injection KORSUVA™ injection 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 Precautions
Dizziness, 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 Reactions The 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 Populations
Severe 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).
Indication KORSUVA™ 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 Pruritus 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.
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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version on businesswire.com: https://www.businesswire.com/news/home/20210823005635/en/
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: Media Claire LaCagnina 6
Degrees 315-765-1462 clacagnina@6degreespr.com
Investors Janhavi Mohite Stern Investor Relations, Inc.
212-363-1200 janhavi.mohite@sternir.com
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