Kapruvia® approved by European Commission for the treatment of moderate-to-severe pruritus in hemodialysis patients
28.4.2022 08:00:00 EEST | Business Wire | Press release
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
iQmetrix to Deliver 2026 Telecom Industry Address and Product Announcements, Unveiling the Next Wave of Intelligent Commerce14.9.2026 20:40:00 EEST | Press release
iQmetrix, the global provider of Intelligent Commerce Operating Systems for telecom, today opened registration for the 2026 Telecom Industry Address and Product Announcements, taking place Wednesday, October 28, 2026. For the first time in the event's history, iQmetrix will run two dedicated virtual sessions: one built specifically for European audiences, alongside its long-running North American event. Both are free to attend. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914992633/en/ Now in its seventh year, the Industry Address has become the telecom channel's annual checkpoint: an unfiltered read on where the market is heading, delivered by a company that sits at the intersection of telcos, retailers, and the partners who serve them. The 2026 edition draws on a year of research and direct conversations across international markets. "We spend the year listening — to telcos, to retailers, to the partners building alon
The Estée Lauder Companies Announces Partnership with Profound to Expand AI Visibility Across Its Global Brand Portfolio14.9.2026 19:32:00 EEST | Press release
The Estée Lauder Companies Inc. (NYSE: EL) today announced a global strategic partnership with Profound, the category-defining AI marketing platform, advancing its ambition to be prestige beauty’s leader in AI-native discovery. The partnership will provide the company with visibility into how its full portfolio of brands is represented across leading generative AI platforms, as well as opportunities to optimize that representation. This partnership establishes the company as the first in prestige beauty to deploy Profound’s capabilities globally across the company’s full portfolio and operationalize Generative Engine Optimization (GEO) and AI marketing at scale. As consumers increasingly turn to ChatGPT, Gemini, and other AI assistants to discover products, compare recommendations, and seek personalized beauty advice before a purchase, The Estée Lauder Companies is partnering with Profound to define the next era of beauty discovery. This partnership will equip the company with a unifie
AMAALA Yacht Club Opens, Putting the Red Sea on the Global Yachting Map14.9.2026 19:00:00 EEST | Press release
Red Sea Global (RSG), the regenerative tourism developer, has announced that AMAALA Yacht Club has officially begun operations, marking a major milestone in establishing the Saudi Red Sea as a new global destination for luxury yachting, sailing and marine tourism. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914160771/en/ AMAALA Yacht Club, the new luxury yachting destination on Saudi Arabia’s Red Sea coast. Nestled within AMAALA Marina Village, the AMAALA Yacht Club is now welcoming founding members and visiting yachts to moor and explore the destination. Located approximately 2,000 nautical miles from Monaco, the club provides a new winter destination for the world’s luxury sailing community, which traditionally migrates from the Mediterranean to the Caribbean or Indian Ocean from October. Positioned closer to the Mediterranean than the Caribbean, AMAALA offers an attractive winter cruising hub and a strategic gateway
Behind the Stage Lights: How Students Learned to Trust Their Voices with Doha Debates14.9.2026 16:40:00 EEST | Press release
During high school years in Model United Nations, Dahlia Al-Ansari learned to argue on behalf of a country she was assigned to represent. But when Doha Debates invited her to join a town hall debate in Toronto this July, she faced an unfamiliar challenge: sharing her own beliefs about a timely issue. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914150232/en/ Students from Qatar, Canada and Mexico during their visit to the University of Toronto as part of the Doha Debates Town Hall experience in Canada. (Photo: AETOSWire) An 18-year-old biological sciences student at Carnegie Mellon University in Qatar, Al-Ansari hadn’t traveled to defend a predetermined position. Instead, she discovered that she was there to think critically, express her own viewpoint and remain open to diverse perspectives. This shift required her to navigate uncharted waters, but “I’m happy that it did,” she says. “It’s showing me the importance of sp
Matt Shafer Joins Golub Capital as Head of Golub Equity Continuation Partners14.9.2026 16:30:00 EEST | Press release
Golub Capital (“the Firm”) today announced the appointment of Matt Shafer as Managing Director and Head of the Firm’s GP-led private equity secondaries strategy, Golub Equity Continuation Partners (“GECP”). In this role, he will be responsible for leading the continued growth and development of the strategy and helping expand the Firm’s equity investment capabilities. Matt will work closely with Greg Cashman, Vice Chair and Co-Head of Golub Capital’s Sponsor Finance practice, to expand Golub Capital’s activity in this growing market. Shafer brings nearly three decades of global experience as an investor, financier and advisor working with private equity firms. He was most recently Head of Capital Solutions and U.S. Private Equity at Northleaf Capital Partners. In this role, Shafer helped lead the firm’s private equity investment activities, including secondaries, co‑investments and structured capital. Prior to Northleaf, he was Partner and Head of Americas Private Equity at Vision Capi
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