Kapruvia® approved by European Commission for the treatment of moderate-to-severe pruritus in hemodialysis patients
April 28 2022 - 12:00AM
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara
Therapeutics, Inc. (Nasdaq: CARA) today announced that the European
Commission has granted marketing authorization to Kapruvia®
(difelikefalin) for the treatment of moderate-to-severe pruritus
associated with chronic kidney disease (CKD) in adult hemodialysis
patients. The marketing authorization, which approves Kapruvia® for
use in all member states of the European Union plus Iceland,
Liechtenstein and Norway, follows the U.S. Food and Drug
Administration (FDA) approval of KORSUVA™ (difelikefalin) injection
in August 2021 for the same indication. Kapruvia® will be the first
therapy available in Europe for the treatment of CKD-associated
pruritus in hemodialysis patients.
“We are very excited about the European Commission’s approval of
Kapruvia®, marking an important milestone on our journey to advance
and fundamentally change the treatment paradigm for people living
with the severe burden of pruritus associated with chronic kidney
disease,” said Dr. Klaus Henning Jensen, Chief Medical Officer of
Vifor Pharma. “We look forward to bringing this first-in-class
therapy to patients in Europe, with launch in first markets
expected in the second half of 2022.”
“The European Commission’s approval of Kapruvia® provides a
much-needed therapy to hemodialysis patients in Europe who suffer
from pruritus,” said Dr. Joana Goncalves, Chief Medical Officer of
Cara Therapeutics. “We are excited to bring an innovative drug to
physicians to help change the way pruritus is managed. We continue
to work with our commercial partner VFMCRP, to fill a significant
unmet medical need among CKD patients with pruritus in both the
U.S. and Europe.”
The approval in Europe is based on pivotal clinical data from
two phase-III trials, KALM-1 and KALM-2, as well as supportive data
from an additional 32 clinical studies. These studies showed that
treatment with Kapruvia® resulted in clinically meaningful
improvements in pruritus severity and in pruritus-related quality
of life components and was found to be generally well tolerated in
patients with moderate-to-severe CKD-associated pruritus.
Contact and
further information: |
Nathalie PonnierGlobal Head
Corporate Communications+41 79 957 96 73 media@viforpharma.com |
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Cara Therapeutics
contacts: |
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Media Contact
Annie
Spinetta 6
Degrees 973-768-2170
aspinetta@6degreespr.com |
Investor
ContactIris Francesconi, PhDCara
Therapeutics203-406-3700investor@caratherapeutics.com |
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About Vifor Pharma Group
Vifor Pharma Group is a global pharmaceuticals company. It aims
to become the global leader in iron deficiency and nephrology. The
company is a partner of choice for pharmaceuticals and innovative
patient-focused solutions across iron, dialysis, nephrology and
rare conditions. Vifor Pharma Group strives to help patients around
the world with severe, chronic and rare diseases lead better,
healthier lives. It specializes in strategic global partnering,
in-licensing and developing, manufacturing and marketing
pharmaceutical products for precision patient care. Vifor Pharma
Group holds a leading position in all its core business activities
and includes the companies: Vifor Pharma, Sanifit Therapeutics, 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.comFor more information, please visit
viforpharma.com.
About Cara Therapeutics
Cara Therapeutics is an early commercial-stage
biopharmaceutical company leading a new treatment paradigm to
improve the lives of patients suffering from pruritus. The
Company’s novel KORSUVA™ (difelikefalin) injection is the first and
only FDA-approved treatment for moderate-to-severe pruritus
associated with chronic kidney disease in adults undergoing
hemodialysis. The Company is developing an oral formulation of
difelikefalin and has initiated Phase 3 programs for the treatment
of pruritus in patients with non-dialysis dependent advanced
chronic kidney disease and atopic dermatitis. Phase 2 trials of
oral difelikefalin are ongoing in primary biliary cholangitis and
notalgia paresthetica patients with moderate-to-severe pruritus.
For more information, visit www.CaraTherapeutics.com and follow the
company on Twitter, LinkedIn and Instagram.
About Chronic Kidney Disease-associated
PruritusCKD-associated pruritus 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. The majority of
dialysis patients (approximately 60 to 70%) report pruritus, with
30 to 40% reporting moderate or severe pruritus.1,2,3 Data from the
ITCH National Registry Study showed that among those with pruritus,
approximately 59%4 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-associated pruritus is also
an independent predictor of mortality and the risk for
hospitalization among hemodialysis patients.
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 the launch of difelikefalin solution for
injection in Europe and the potential of difelikefalin 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
2021 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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