Recommendation will enable eligible patients
in England, Wales and Northern
Ireland to access the first licensed treatment for
moderate-to-severe chronic kidney disease (CKD)-associated pruritus
in adult patients on haemodialysis
ST. GALLEN, Switzerland and STAMFORD, Conn., May
18, 2023 /PRNewswire/ -- Vifor Fresenius Medical Care Renal
Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today
announced that England's National
Institute for Health and Care Excellence (NICE) has recommended
Kapruvia® for the treatment of moderate-to-severe
CKD-associated pruritus in adult patients on haemodialysis. The
decision follows authorisation from the UK's Medicines and
Healthcare products Regulatory Agency (MHRA) in April 2022.
"The recommendation of Kapruvia® by NICE is a
key step on our journey to bring this breakthrough treatment to
in-centre haemodialysis patients living with moderate-to-severe
CKD-associated pruritus in the UK," said Fabio Dorigotti, Head
Global Medical Affairs of CSL Vifor. "We look forward to continue
working with the National Health Service to ensure access to this
important medicine for patients as quickly as possible."
"We are pleased that Kapruvia® will be available to
CKD patients in England,
Wales and Northern
Ireland who are undergoing haemodialysis and suffering from
moderate-to-severe CKD-associated pruritus," said Christopher Posner, President and Chief
Executive Officer of Cara Therapeutics. "Together with VFMCRP, we
are committed to bringing our first-of-its kind therapy to
providers and patients around the world to help change the way
pruritus is managed."
"Chronic kidney disease-related itch is common for people on
haemodialysis and represents a significant unmet need; leading to
poor sleep and reduced quality of life for patients," said Dr.
Kieran McCafferty, Consultant
Nephrologist, Barts Health NHS Trust. "We now have an option to
help reduce the burden of CKD-related itch."
MHRA approval and the NICE recommendation were 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.
About CSL Vifor
CSL Vifor is a global partner of choice for pharmaceuticals
and innovative, leading therapies in iron deficiency and
nephrology. We specialize in strategic global partnering,
in-licensing and developing, manufacturing and marketing
pharmaceutical products for precision healthcare, aiming to help
patients around the world lead better, healthier lives.
Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint
company Vifor Fresenius Medical Care Renal Pharma (with Fresenius
Medical Care).
The parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in
Melbourne, Australia, employs
32,000 people and delivers its lifesaving therapies to people
in more than 100 countries. For more information about CSL Vifor
visit, www.cslvifor.com.
About Cara Therapeutics
Cara Therapeutics is a commercial-stage biopharmaceutical
company leading a new treatment paradigm to improve the lives of
patients suffering from pruritus. The Company's
Kapruvia® (difelikefalin) injection is the first
and only MHRA-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 Phase 3 programs ongoing for the treatment of
pruritus in patients with non-dialysis dependent advanced chronic
kidney disease and atopic dermatitis. In addition, the Company has
initiated a Phase 2/3 program of oral difelikefalin for the
treatment of moderate-to-severe pruritus in patients with notalgia
paresthetica. For more information, visit www.CaraTherapeutics.com
and follow the company on Twitter, LinkedIn and Instagram.
About Chronic Kidney Disease-Associated Pruritus
CKD-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.1 The majority of dialysis patients in the
UK (approximately 70%) report pruritus, with nearly half reporting
moderate or severe pruritus.2 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 gabapentinoids, 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.3
References:
- Rayner, H. C., Larkina, M., Wang, M., Graham-Brown, M., van der
Veer, S. N., Ecder, T., … Pisoni, R. L. (2017). International
Comparisons of Prevalence, Awareness, and Treatment of Pruritus in
People on Hemodialysis. Clinical journal of the American Society of
Nephrology, 12(12), 2000–2007. doi:10.2215/CJN.03280317
- Nidhi Sukul, Angelo Karaboyas, Philipp A. Csomor, Thilo
Schaufler, Warren Wen,
Frédérique Menzaghi, Hugh C. Rayner,
Takeshi Hasegawa, Issa Al Salmi, Saeed
M.G. Al-Ghamdi, Fitsum Guebre-Egziabher, Pablo-Antonio Urena-Torres, and Ronald L. Pisoni. Self-reported Pruritus and
Clinical, Dialysis-Related, and Patient-Reported Outcomes in
Hemodialysis Patients. Kidney Medicine 3(1):42-53. Published online
2020.
- 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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