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
ATLAS Infrastructure Invests in H2O America, Backs Long-Term Growth Strategy10.3.2026 19:29:00 EET | Press release
ATLAS Infrastructure (“ATLAS”) is a specialist Global Listed Infrastructure investor managing funds on behalf of long-term infrastructure clients. Following the recent equity placement, ATLAS’s actively managed accounts hold ~10.8% voting and economic interest in H2O America (“H2O”). ATLAS was pleased to support H2Os long‑term strategy to invest in local water and wastewater utility operations through our participation in the recent equity raise. ATLAS recognises the disciplined approach from H2O management which focuses on organic investment in existing businesses alongside targeted and accretive transactions such as the acquisition of Quadvest which materially expands H2O’s regulated water footprint in a premium high‑growth jurisdiction. The upsized equity raise, anchored by ATLAS, supports the company strategy through providing significant balance sheet capacity and financial flexibility well into the Company’s 2026-2030 CapEx plan. “Increased investment in water utilities is essent
Svante and Integrated Packaging Company Advance U.S. Biogenic CDR Project to Feasibility10.3.2026 15:57:00 EET | Press release
Svante Technologies Inc. (“Svante”) announced today that its bioenergy with carbon capture and storage (BECCS) project at a paper mill in the Southeast U.S. has progressed to the feasibility study phase. The project is being developed in partnership with an integrated sustainable packaging company, following an extensive screening and pre-feasibility study conducted across several of the partner’s mills. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310319382/en/ During the feasibility study phase, the companies will complete further engineering and design activities, cost and schedule estimates, and risk assessments required to evaluate commercial viability ahead of a future engineering study leading to final investment decision (FID). Svante’s subsidiary, Svante Development Inc., is co-investing in this phase with the mill owner. The project is designed to capture and permanently store more than 500,000 tonnes per year
Forbes 40th Annual World’s Billionaires List10.3.2026 15:43:00 EET | Press release
Forbes releases its 40th-annual World’s Billionaireslist, the definitive ranking of the planet’s richest people. Wealth surged to unprecedented levels over the past year, with fortunes climbing at a record pace. This year’s list features 3,428 billionaires, the most since the list’s inception in 1987. The world’s wealthiest people are worth a record $20.1 trillion combined, up from $16.1 trillion in 2025. Elon Musktops the Billionaires list for the second year in a row and is the richest person ever recorded, worth an estimated $839 billion. His net worth skyrocketed by half of a trillion dollars from last year, thanks to a rise in the value of Tesla, and SpaceX which is aiming to go public in 2026. Musk is the first person ever recorded to reach the $800 billion mark, as he moves toward becoming the world’s first trillionaire. “It’s the year of the billionaire,” said Chase Peterson-Withorn, Forbes Senior Editor, Wealth. “The planet added more than one billionaire per day over the past
Andersen Global Expands African Presence with Addition of Bravura10.3.2026 15:30:00 EET | Press release
Andersen Global strengthens its presence in Africa through a Collaboration Agreement with Bravura, a leading independent tax and financial advisory firm based in South Africa and Namibia. Founded in 1999, Bravura provides tax and financial advisory solutions to listed and private companies, entrepreneurs, and high-net-worth families across the region. Bravura combines deep financial expertise with an entrepreneurial mindset to deliver tailored strategies that drive value. The firm’s multidisciplinary team provides advisory services in mergers and acquisitions, capital raising, corporate restructuring, and succession planning. Additionally, the firm offers tax and accounting strategy, international tax structuring, global mobility, and exchange control compliance solutions. “At Bravura, we’re driven to redefine standards and deliver bespoke, results-driven solutions that create lasting value for our clients,” said Ian Matthews, head of business development at Bravura. “Our collaboration
Adtran sets intra-data center benchmark with all-new ultra-low-power LiteWave800™ LPO module10.3.2026 15:00:00 EET | Press release
Adtran today launched LiteWave800™, an ultra‑low‑power 800Gbit/s DR8 linear pluggable optics (LPO) module engineered to help data centers address the power, latency, thermal and bandwidth demands of modern AI and machine-learning (ML) workloads. As GPU clusters grow and short-reach links scale across dense server racks, operators need 800Gbit/s optics that deliver higher capacity within strict power and cooling limits. LiteWave800™ answers this challenge with a fully re-engineered architecture that significantly reduces energy consumption. Operating at just 1pJ/bit and consuming only 0.8W, it establishes a new power class for 800Gbit/s optics, delivering far lower energy per bit than today’s first‑generation LPOs and mainstream DSP-based pluggable transceivers. Adtran will showcase LiteWave800™ at OFC 2026 in Los Angeles from March 17 to 19. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310344607/en/ Adtran's LiteWave800
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