VFMCRP and Cara Therapeutics announce European Medicines Agency has accepted to review the Marketing Authorization Applicatio...
March 30 2021 - 1:00AM
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara
Therapeutics, Inc. (Nasdaq: CARA) today announced that the
European Medicines Agency (EMA) accepted to review the Marketing
Authorization Application (MAA) for difelikefalin injection for the
treatment of pruritus associated with chronic kidney disease in
hemodialysis patients. The EMA will review the application under
the centralized marketing authorization procedure.
The EMA filing is supported by positive clinical data from the
two pivotal phase-III trials KALM-1 and KALM-2, as well as
supportive data from an additional 32 clinical studies. If
approved, difelikefalin would receive marketing authorization
in all member states of the European Union (EU), as well as
in Iceland, Liechtenstein and Norway. EMA’s
decision on the EU MAA is expected Q2-2022.
“Following the US FDA’s acceptance and priority review for the
New Drug Application for difelikefalin at the beginning of March
2021, this is another major step forward on our mission to help
kidney patients around the world lead better, healthier lives,”
commented Stefan Schulze, CEO of Vifor Pharma Group. “Together with
our partner Cara Therapeutics, we remain focused on making this
innovative therapy available in Europe, if approved, for patients
with chronic kidney disease-associated pruritus, a condition that
has been historically underdiagnosed and undertreated.”
“The acceptance of the EU regulatory application for
difelikefalin marks another major milestone towards our goal of
bringing this first-in-class therapeutic to the significant number
of hemodialysis patients worldwide with chronic intractable
pruritus,” said Derek Chalmers, Ph.D., D.Sc., President and Chief
Executive Officer of Cara Therapeutics. “We look forward to working
closely with our partner, Vifor Pharma, through the EMA review
process and in preparation for commercial launch across European
territories, if approved.”
Contact and
further information: |
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 |
|
Cara
Therapeutics contacts: |
Media Contact Claire LaCagnina6
Degrees315-765-1462clacagnina@6degreespr.com |
Investor ContactJanhavi MohiteStern Investor
Relations, Inc.212-363-1200janhavi.mohite@sternir.com |
|
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 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 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. 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 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 regulatory approval of difelikefalin solution for
injection and the potential timeline for EMA review and approval of
the MAA 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
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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