Kapruvia® (difelikefalin) recommended by England’s NICE for the treatment of adults with moderate-to-severe CKD-associated pruritus
18 5월 2023 - 3:00PM
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
CSL Vifor Media Contact
Thomas HutterM. +41 79 957 96 73E. media@viforpharma.com
Cara Therapeutics Contacts:
Media ContactAnnie Spinetta6 DegreesM. +1
973-768-2170 E. aspinetta@6degreespr.com
Investor ContactIris Francesconi, PhDCara
TherapeuticsM. +1 203-406-3700E. investor@caratherapeutics.com
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
Cara Therapeutics (NASDAQ:CARA)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Cara Therapeutics (NASDAQ:CARA)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024