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Kapruvia (Difelikefalin) Recommended by England's NICE for the Treatment of Adults With Moderate-to-severe CKD-associated Pruritus

Kapruvia (Difelikefalin) Recommended by England's NICE for the Treatment of Adults With Moderate-to-severe CKD-associated Pruritus

Kapruvia(Difelikefalin)被英格兰 NICE 推荐用于治疗患有中度至重度 CKD 相关瘙痒症的成年人
GlobeNewswire ·  2023/05/18 14:00

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

该建议将使英格兰、威尔士和北爱尔兰符合条件的患者能够在接受血液透析的成年患者中度至重度慢性肾脏病 (CKD) 相关瘙痒症中度至重度获得许可的治疗

ST. GALLEN, Switzerland and STAMFORD, Conn., May 18, 2023 (GLOBE NEWSWIRE) -- 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.

ST。瑞士加伦和康涅狄格州斯坦福德,2023年5月18日(GLOBE NEWSWIRE)——Vifor Fresenius Medical Care Lenal Pharma(VFMCRP)和Cara Therapeutics, Inc.(纳斯达克股票代码:CARA)今天宣布,英格兰国家健康与护理卓越研究所(NICE)已推荐Kapruvia 用于治疗接受血液透析的成年患者的中度至重度 CKD 相关瘙痒。该决定是在英国药品和保健产品监管局 (MHRA) 于 2022 年 4 月批准后作出的。

"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."

“卡普鲁维亚的建议 by NICE是我们在英国为患有中度至重度CKD相关瘙痒症的中心血液透析患者提供这种突破性治疗的关键一步。” CSL Vifor全球医学事务主管法比奥·多里戈蒂说。“我们期待继续与国家卫生局合作,确保患者尽快获得这种重要药物。”

"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."

“我们很高兴卡普鲁维亚 将提供给英格兰、威尔士和北爱尔兰正在接受血液透析并患有中度至重度CKD相关瘙痒症的CKD患者。” Cara Therapeutics总裁兼首席执行官克里斯托弗·波斯纳说。“我们与VFMCRP一起,致力于将我们首创的疗法带给世界各地的提供者和患者,以帮助改变瘙痒症的管理方式。”

"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."

Barts Health NHS Trust的肾脏科顾问医生基兰·麦卡弗蒂博士说:“慢性肾脏病相关的瘙痒在接受血液透析的人中很常见,是一种未得到满足的严重需求;导致患者睡眠不佳和生活质量下降。”“我们现在可以选择帮助减轻 CKD 相关瘙痒的负担。”

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.

MHRA 的批准和 NICE 的建议得到了在美国进行的两项关键的 III 期试验(KALM-1)的积极数据的支持。(新英格兰医学杂志 2020;382:222-232)和全球 KALM-2,以及来自另外 32 项临床研究的支持数据。

About CSL Vifor

关于 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).

CSL Vifor 是缺铁和肾脏病领域药物和创新领先疗法的全球首选合作伙伴。我们专注于全球战略合作、许可和开发、制造和营销用于精准医疗的药品产品,旨在帮助世界各地的患者过上更好、更健康的生活。CSL Vifor总部位于瑞士圣加仑,还包括合资公司Vifor Fresenius Medical Care Lenal Pharma(与费森尤斯医疗保健)。

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, .

总部位于澳大利亚墨尔本的母公司CSL(ASX: CSL;USOTC: CSLY)拥有32,000名员工,为100多个国家的人们提供救生疗法。有关 CSL Vifor 的更多信息,请访问。

About Cara Therapeutics

关于卡拉疗法

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 and follow the company on Twitter, LinkedIn and Instagram.

Cara Therapeutics是一家处于商业阶段的生物制药公司,引领一种新的治疗模式,以改善瘙痒症患者的生活。该公司的卡普鲁维亚 (difelikefalin)注射剂是第一种也是唯一一种获得MHRA批准的治疗接受血液透析的成年人与慢性肾脏病相关的中度至重度瘙痒的治疗方法。该公司正在开发difelikefalin的口服配方,并正在进行3期项目,用于治疗非透析依赖性晚期慢性肾脏病和特应性皮炎患者的瘙痒。此外,该公司还启动了口服difelikefalin的2/3期项目,用于治疗夜间疼痛患者的中度至重度瘙痒。欲了解更多信息,请访问并在推特、领英和Instagram上关注该公司。

About Chronic Kidney Disease-Associated Pruritus

关于慢性肾脏病相关的瘙痒

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

CKD 相关瘙痒症是一种难以治愈的系统性瘙痒,在接受透析的慢性肾脏病患者中发生的频率和强度都很高。据报道,未接受透析的 III-V 期 CKD 患者也出现了瘙痒。1 在英国,大多数透析患者(约70%)报告了瘙痒,近一半的人报告了中度或重度瘙痒。2 ITCH国家登记研究的最新数据显示,在瘙痒症患者中,大约有59%的人在一年多的时间里每天或几乎每天都会出现症状。鉴于其与 CKD/ESRD 的关系,大多数患病患者将在数月或数年内继续出现症状,而目前使用的止痒疗法,例如抗组胺药和加巴喷丁类药物,无法提供持续、充分的缓解。中度至重度慢性瘙痒症一再被证明会直接降低生活质量,导致损害生活质量的症状(例如睡眠质量差),并与抑郁症有关。3

CSL Vifor Media Contact

CSL Vifor 媒体联系人

Thomas Hutter
M. +41 79 957 96 73
E. media@viforpharma.com

托马斯·哈特
M. +41 79 957 96 73
E. media@viforpharma.com

Cara Therapeutics Contacts:

卡拉疗法联系人:

Media Contact
Annie Spinetta
6 Degrees
M. +1 973-768-2170
E. aspinetta@6degreespr.com

媒体联系人
安妮·斯皮内塔
6 度
M. +1 973-768-2170
E. aspinetta@6degreespr.com

Investor Contact
Iris Francesconi, PhD
Cara Therapeutics
M. +1 203-406-3700
E. investor@caratherapeutics.com

投资者联系人
艾里斯·弗朗切斯科尼博士
卡拉疗法
M. +1 203-406-3700
E. investor@caratherapeutics.com

References:

参考文献:

  1. 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
  2. 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.
  3. Mathur VS, et al. A longitudinal study of Uremic Pruritus in hemodialysis patients. Clin J Am Soc Nephrol. 2010; 5(8):1410-1419
  1. Rayner、H.C.、Larkina、M.、Wang、M.、Graham-Brown、M.、van der Veer、S. N.、Eder、T.Pisoni,R.L.(2017)。血液透析患者瘙痒症患病率、认识和治疗的国际比较。《美国肾脏病学会临床杂志》,12 (12),2000—2007。doi: 10.2215/cjn.03280317
  2. Nidhi Sukul、Angelo Karaboyas、Philipp A. Csomor、Thilo Schaufler、Warren Wen、Frederique M.G.Rayner、Hagmawa、Issa Al Salmi、Saeed M.G. Al-Ghamdi、Fitsum Guebre-Egziabher、Pablo-Antonio Urena-Torres 和 Ronald L. Pisoni。血液透析患者自我报告的瘙痒和临床、透析相关和患者报告的预后。肾脏医学 3 (1): 42-53。2020 年在线发布。
  3. Mathur VS 等人。一项关于血液透析患者尿毒症瘙痒症的纵向研究。clin J Am Soc Nephrol。2010;5 (8): 1410-1419

译文内容由第三方软件翻译。


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