Kapruvia® approved by European Commission for the treatment of moderate-to-severe pruritus in hemodialysis patients
Regulatory News:
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220427005801/en/
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.
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.com
For 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 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. 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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220427005801/en/
Contact information
Nathalie Ponnier
Global Head Corporate Communications
+41 79 957 96 73
media@viforpharma.com
Cara Therapeutics contacts:
Media Contact
Annie Spinetta
6 Degrees
973-768-2170
aspinetta@6degreespr.com
Investor Contact
Iris Francesconi, PhD
Cara Therapeutics
203-406-3700
investor@caratherapeutics.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Tinnitus Research: Novel Compound AC102 Makes Constant Ear Noise Disappear in Preclinical Model3.7.2025 13:02:00 EEST | Press release
The novel compound AC102 almost completely reversed tinnitus in a preclinical model after a single dose. At the same time, the damaged connections between the auditory nerve and inner ear sensory cells were restored. These findings were recently published in the prestigious International Journal of Molecular Sciences in a joint study conducted by Erlangen University Hospital and Berlin-based drug developer AudioCure. As there is currently no causal treatment for tinnitus, there is a high medical need. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702168211/en/ In 10-20% of tinnitus cases, the noise in the ear is so severe that it significantly impairs the quality of life of those affected. (Source: AI-generated) In the current study, AC102 was administered to the middle ear of one experimental group after acoustic trauma, while a second group received a placebo. Although both groups initially showed signs of tinnitus, th
H2SITE Secures EIC Accelerator Funding to Deploy a Flagship 1 TPD Ammonia Cracker Using Membrane Reactor Technology at a Port in North-West Europe3.7.2025 09:40:00 EEST | Press release
H2SITE has been awarded the EIC (European Innovation Council) Accelerator program for a project aimed at deploying a first-of-its-kind ammonia cracking unit capable of producing 1 ton of high-purity hydrogen per day. The system is based on H2SITE’s proprietary palladium-based membrane reactor technology, which enables the simultaneous catalytic decomposition of ammonia and selective hydrogen separation within a single unit. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702142283/en/ Ammonia Cracker using Membrane Reactor Technology This breakthrough technology offers several compelling advantages over conventional ammonia cracking processes: Lowest Levelized Cost of Hydrogen (LCOH) from ammonia due to high efficiency and integrated operation Reduced energy consumption, operating at significantly lower temperatures (400–450 °C) than traditional cracking methods (typically 600–800 °C) High-purity hydrogen output, compliant
ISDA and Ant International Lead New Industry Report on Use of Tokenised Bank Liabilities for FX Settlement and Cross-Border Payments Under Project Guardian3.7.2025 09:00:00 EEST | Press release
The International Swaps and Derivatives Association (ISDA) and Ant International led the Project Guardian FX industry group to develop a new report for implementing tokenised bank liabilities and shared ledger in cross-border payments and foreign exchange (FX) settlement. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702791535/en/ Report on Use of Tokenised Bank Liabilities for Transaction Banking by ISDA and Ant International, under the Monetary Authority of Singapore's (MAS) Project Guardian The joint report is produced under the Monetary Authority of Singapore's (MAS) Project Guardian, a global collaboration between policymakers and key industry players to enhance liquidity and efficiency of financial markets through asset tokenisation. ISDA and Ant International are members of the industry group and lead the FX workstream to develop FX data specifications, risk management frameworks and FX documentation. Other contri
Curve Pay and Thales Join Forces to Securely Transform Digital Wallets on iPhone3.7.2025 09:00:00 EEST | Press release
Curve, the ultimate digital wallet, today announced deepening its collaboration with Thales, the global leader in advanced technologies, delivering secure modern payment solutions for financial institutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702696837/en/ Thales D1 Platform to power CURVE PAY (Photo: Thales) This partnership comes on the back of Curve launching Curve Pay on iOS, marking a watershed moment in mobile payments. This partnership is a significant step to reshaping everyday spending, allowing Curve customers to benefit from NFC payment directly in the Curve App for contactless payments in store for all end-users on iOS and Android. Curve Pay is underpinned by Thales’ D1 platform on iOS and Android in Europe which allows customers to digitize a payment card through a mobile wallet. The cloud-based D1 platform operates in real time, enabling seamless integration with existing systems to deliver secur
Medimaps Group Launches In Europe TBS Osteo Next-Generation Software For Advanced Bone Microarchitecture Assessment3.7.2025 09:00:00 EEST | Press release
Medimaps Group S.A., a global leader in AI-driven bone microarchitecture imaging solutions, announces the European launch of its MDR-cleared next-generation TBS Osteo Advanced software. Following the product launch in the United States last month, this next milestone reflects the company's commitment to advancing osteoporosis detection and bone health management worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702082335/en/ Medimaps' TBS Osteo next-generation software The TBS Osteo Advanced software delivers refined correction for soft tissue thickness anterior to the lumbar spine, ensuring inclusivity of TBS assessment across a wide range of body phenotypes. It also introduces new system management capabilities, allowing hospitals and healthcare networks to centrally manage the TBS software on their DXA systems fleet, and to standardize workflows across multiple locations. These improvements enhance operational
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom