VFMCRP and Cara Therapeutics announce European Medicines Agency has accepted to review the Marketing Authorization Application for difelikefalin
30.3.2021 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/20210329005652/en/
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the European Medicines Agency (EMA) accepted to review the Marketing Authorization Application (MAA) for difelikefalin injection for the treatment of pruritus associated with chronic kidney disease in hemodialysis patients. The EMA will review the application under the centralized marketing authorization procedure.
The EMA filing is supported by positive clinical data from the two pivotal phase-III trials KALM-1 and KALM-2, as well as supportive data from an additional 32 clinical studies. If approved, difelikefalin would receive marketing authorization in all member states of the European Union (EU), as well as in Iceland, Liechtenstein and Norway. EMA’s decision on the EU MAA is expected Q2-2022.
“Following the US FDA’s acceptance and priority review for the New Drug Application for difelikefalin at the beginning of March 2021, this is another major step forward on our mission to help kidney patients around the world lead better, healthier lives,” commented Stefan Schulze, CEO of Vifor Pharma Group. “Together with our partner Cara Therapeutics, we remain focused on making this innovative therapy available in Europe, if approved, for patients with chronic kidney disease-associated pruritus, a condition that has been historically underdiagnosed and undertreated.”
“The acceptance of the EU regulatory application for difelikefalin marks another major milestone towards our goal of bringing this first-in-class therapeutic to the significant number of hemodialysis patients worldwide with chronic intractable pruritus,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “We look forward to working closely with our partner, Vifor Pharma, through the EMA review process and in preparation for commercial launch across European territories, if approved.”
About Vifor Pharma Group
Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions. Vifor Pharma Group strives to help patients around the world with severe and chronic diseases lead better, healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma 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.
About Cara Therapeutics
Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs. Cara is developing a novel and proprietary class of product candidates, led by KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist that targets the body’s peripheral nervous system, as well as certain immune cells. In two Phase 3 trials, KORSUVA injection has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP). Oral KORSUVA™ has successfully completed a Phase 2 trial for the treatment of pruritus in patients with CKD and is currently in Phase 2 trials in atopic dermatitis, primary biliary cholangitis and notalgia paresthetica patients with moderate-to-severe pruritus.
About Chronic Kidney Disease-associated Pruritus (CKD-aP)
CKD-aP 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 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 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-aP 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 regulatory approval of difelikefalin solution for injection and the potential timeline for EMA review and approval of the MAA 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 2020 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/20210329005652/en/
Contact information
Contact and further information:
Media Relations
Nathalie Ponnier
Global Head Corporate Communications
+41 79 957 96 73
media@viforpharma.com
Investor Relations
Julien Vignot
Head of Investor Relations
+41 58 851 66 90
investors@viforpharma.com
Cara Therapeutics contacts:
Media Contact
Claire LaCagnina
6 Degrees
315-765-1462
clacagnina@6degreespr.com
Investor Contact
Janhavi Mohite
Stern Investor Relations, Inc.
212-363-1200
janhavi.mohite@sternir.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
QI Tech and Ant International’s Bettr Partner to Expand Credit Access for E-Commerce Merchants and Consumers in Brazil26.6.2026 07:26:00 EEST | Press release
QI Tech, a leading financial services infrastructure provider, has joined forces with Bettr, a leading provider of inclusive and embedded financial services under Ant International, to expand credit solutions for e-commerce sellers and shoppers. The strategic partnership aligns with Brazil’s ongoing efforts to promote inclusive finance, launching targeted lending programs directly within digital marketplaces. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260622444217/en/ Consumers can select BNPL option at checkout, facilitated by Bettr In its initial phase, QI Tech is collaborating with Bettr to provide working capital loans for small and medium-sized e-commerce businesses, allowing them to expand inventory and scale operations effectively. This partnership also includes a consumer-facing Buy Now, Pay Later (BNPL) option offered at the point of purchase, enabling shoppers on AliExpress to pay in installments. Both services
I-Pulse Signs Definitive Agreement with the U.S. Department of Commerce for $250 Million CHIPS R&D Award25.6.2026 21:53:00 EEST | Press release
I-Pulse Co-founders Robert Friedland, CEO, and Laurent Frescaline, CTO, announced today a definitive agreement with the U.S. Department of Commerce’s CHIPS Research and Development Office for a $250 million award for the further development of I-Pulse’s proprietary semiconductor and pulsed power technology. “With today’s announced investment, the Trump administration is strengthening America’s capabilities and enhancing its national and energy security goals,” said Secretary of Commerce, Howard Lutnick. Co-founder Robert Friedland said: “We are excited to partner with the U.S. government to advance our unique, American technology suite to benefit our great nation. This award supports the development of world-leading critical components in the pulsed power technology stack, with profound implications for energy security and national defense.” The CHIPS award strengthens U.S. supply chain resilience by boosting domestic semiconductor manufacturing and reducing reliance on foreign-made se
Burjeel Holdings Prices First MENA Healthcare Sukuk Since 2018, 3.2x Oversubscribed25.6.2026 20:31:00 EEST | Press release
Burjeel Holdings, a leading super-specialty healthcare group in the GCC listed on the Abu Dhabi Securities Exchange, priced its inaugural USD 500 million Regulation S 5-year senior unsecured Sukuk offering due 2031 under its newly established USD 1.5 billion Senior Unsecured Sukuk Programme. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260625449702/en/ Burjeel Holdings’ inaugural Sukuk was priced at a 7.000 % profit rate and a yield of 7.125% (Photo: AETOSWire) The offering attracted significant demand from high-quality international and regional investors, with the orderbook peaking at USD 1.6 billion, representing 3.2x oversubscription. The strength of the orderbook enabled Burjeel to tighten pricing from initial price thoughts in the mid-7% area, with the Sukuk priced at a 7.000% profit rate and a yield of 7.125%, representing the lowest 5-year yield by a GCC-based private non-investment grade corporate issuer since 202
Fossil Fuels Are a Thing of the Past; The Future Is Renewable: The Smarter E Europe Concludes With a Clear Message25.6.2026 20:03:00 EEST | Press release
Packed halls, a vibrant atmosphere and a buzzing vibe – after three days, The smarter E Europe 2026, Europe’s largest alliance of exhibitions for the energy industry, has come to a successful close. The event held at Messe München offered a glimpse of a future-oriented energy world powered by renewables. A strong signal with a clear message went out to the world from the Bavarian capital: The future is renewable. Renewable energies can help ensure a reliable, secure and cost-effective energy supply around the clock, seven days a week. A total of 2,650 exhibitors from 52 countries – many of whom had expanded their booth space compared with the previous year – demonstrated how this can work. More than 66 percent of exhibitors were from outside of Germany. They presented innovative and market-ready products ranging from virtual power plants, smart grid and load control, smart charging solutions, storage technologies and PV hybrid systems to digital platforms transparently and flexibly.The
HeyGen Doubles to $200M ARR in Eight Months on the Rise of Identity-First AI Video25.6.2026 19:02:00 EEST | Press release
HeyGen, the identity-first AI video platform, today announced it has surpassed $200 million in annual recurring revenue, doubling in eight months. The milestone reflects a rapid shift in how individuals, small businesses, and enterprises adopt AI video: as a scalable layer for human communication across languages, formats, and audiences. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260625305891/en/ HeyGen passes $200M in ARR HeyGen's community now spans more than 30 million users in 196 countries and 175+ languages & dialects, from solopreneurs creating professional social videos for the first time to 85% of the Fortune 100 — who together have created more than 118 million videos. That growth has come with rare capital efficiency: HeyGen generates roughly $2.70 in ARR for every dollar of equity capital raised, making it one of the most capital-efficient venture-backed AI companies in the world. "Crossing $200 million in AR
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