VIFOR-PHARMA
8.3.2021 07:02:11 CET | Business Wire | Press release
Regulatory News:
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210307005039/en/
Vifor Pharma and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for the New Drug Application (NDA) for KORSUVA™ (difelikefalin) solution for injection for the treatment of moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date for KORSUVA™ is 23 August 2021. The FDA stated that currently it is not planning to hold an advisory committee meeting to discuss the application.
The FDA grants Priority Review to drug applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. The NDA filing is 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.
“We are delighted that the FDA accepted and granted Priority Review for this breakthrough therapy. Pruritus in hemodialysis patients is a debilitating condition with a significant impact on quality of life and increased risk for hospitalization and mortality. It impacts up to 40% of dialysis patients around the world. If KORSUVA™ is approved, we will be able to offer a medicine that is in line with our aim to deliver innovative therapies to patients with high unmet medical needs. We are highly committed to bringing this important new treatment to patients in the US as soon as possible following FDA approval, together with our partner Cara Therapeutics”, commented Stefan Schulze, CEO of Vifor Pharma Group.
“The FDA acceptance for filing and granting of Priority Review for the KORSUVA NDA marks a significant milestone for Cara and for the substantial number of hemodialysis patients with chronic intractable pruritus,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “FDA’s agreement to expedite the timeline through Priority Review designation aligns with our understanding of the therapeutic potential of KORSUVA to fundamentally change the treatment paradigm for this serious unmet need. We look forward to working with the FDA through the review process and, along with our commercial partner, Vifor Pharma, remain focused on preparing for the U.S. launch of KORSUVA injection, if approved.”
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. Aggregate, longitudinal, multi-country studies estimate the weighted prevalence of CKD-aP to be approximately 40% in patients with end-stage renal disease (ESRD), with approximately 25% of patients reporting severe pruritus. 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 among hemodialysis patients, mainly related to increased risk of inflammation and infections.
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.
* The FDA has conditionally accepted KORSUVA™ as the trade name for difelikefalin injection in the US. CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.
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-lII 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-II trial for the treatment of pruritus in patients with CKD and is currently in phase-II trials in atopic dermatitis, primary biliary cholangitis and notalgia paresthetica patients with moderate-to-severe pruritus
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 KORSUVA™ solution for injection and the potential timeline for FDA review of the NDA and the potential of KORSUVA™ 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210307005039/en/
Link:
About Business Wire
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
New Research Reveals the Next Wealth Management Divide: AI Rewards Firms Built to Scale10.6.2026 12:34:00 CEST | Press release
The market is entering a new phase where innovation alone is no longer a differentiator, and AI in particular risks widening operational gaps across banking, wealth and asset management. Weak foundations, poor execution and lack of strategic sourcing models are the structural barriers preventing institutions from translating technology investment into scalable, profitable growth.Key takeaways Leaders are significantly more likely to report profitability increases above 15%, demonstrating a direct link between scalability and financial performance. Integration issues across systems are identified as the single biggest barrier to scalable growth. Externalisation and as-a-service models are a primary lever of profitable scale, regardless of firm’s size. Competitive advantage will not come from where AI is deployed, but from how it is embedded and translated into business outcomes. The strategy is the sequence: foundations first, externalisation as accelerator, AI as amplifier. The next co
From Cutting-Edge Research to Industry: Focused Energy Plans Spin-Off of Sourcelight10.6.2026 11:38:00 CEST | Press release
Following its successful USD 240 million financing round, Focused Energy is continuing to systematically advance the industrialization of laser fusion as its core business. At the same time, the company plans to consolidate its activities in the field of laser-driven radiation sources into an independent entity under the name Sourcelight. With this move, Focused Energy is laying the groundwork for the industrial transfer of selected technological building blocks emerging from its laser fusion development. The spin-off demonstrates how cutting-edge research can give rise to new industry: scientific excellence is translated into industrial applications with strong value creation and growth potential. Sourcelight is intended to bring the LDRS (Laser-Driven Radiation Sources) technology developed by Focused Energy into targeted industrial applications. The technology combines laser-driven high-energy X-rays and neutrons in a single system. This enables not only high-resolution imaging, but
Cosylab and Heron Neutron Medical Corp. Sign Letter of Intent to Advance Global Deployment of Accelerator-Based BNCT Systems10.6.2026 11:30:00 CEST | Press release
Cosylab and Heron Neutron Medical Corp. announced today, 10 June 2026, the signing of a Letter of Intent to establish a strategic framework for joint market development to support the global deployment of Accelerator-Based Boron Neutron Capture Therapy (AB-BNCT) systems. The collaboration aims to accelerate the development and integration of sophisticated software solutions for use with AB-BNCT while strengthening AB-BNCT's international market access and business development. By combining Cosylab's proven expertise in mission-critical software and complex system integration with Heron's end-to-end BNCT platforms, the partnership aims to drive broader global clinical adoption of this highly targeted cancer treatment modality. "AB-BNCT is emerging as one of the most promising approaches for treating difficult-to-treat and recurrent cancers," said Mark Pleško, Chief Executive Officer of Cosylab. "This collaboration reinforces our strategic focus on advancing radiation therapy technologie
GlobalFoundries and Qualinx Demonstrate First European Sovereign Manufacturing Flow for Security‑Critical Semiconductors10.6.2026 11:25:00 CEST | Press release
First end-to-end European chip manufacturing flow proven for aerospace, defence, IoT, consumer electronics and critical infrastructure GlobalFoundries (GF) and Qualinx today announced the successful completion of the first fully European-based, end-to-end semiconductor manufacturing flow at GlobalFoundries’ Dresden fab on its FDX technology. The milestone demonstrates that security-critical chips for aerospace, defence and critical infrastructure can be designed, manufactured and delivered entirely within Europe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260610196220/en/ In this partnership, Qualinx served as the launch customer with a sophisticated GNSS SoC design for secure Positioning, Navigation and Timing (PNT) applications. The QLX3xx design targets sovereign GNSS-based PNT solutions for aerospace, defence and critical infrastructures—such as resilient timing and synchronization networks and highly integrated, ult
LTM Introduces BlueVerse™ Currency to Enable Outcome-Based Pricing in the Agentic AI Era10.6.2026 10:30:00 CEST | Press release
LTM, the Business Creativity partner to the world’s largest enterprises, today introduced BlueVerse™ Currency, an AI-linked commercial model that prices enterprise work by outcomes rather than effort consumed as enterprises scale agentic AI across core processes. BlueVerse Currency brings together the full BlueVerse stack—People (expertise on demand), Accelerators (reusable assets that speed delivery), Agents (autonomous AI workforce), Platforms (orchestration layer to scale delivery), and Tokens (compute and model usage)—into a single commercial construct. It introduces outcome-linked pricing tied to measurable business results, enabling shared productivity gains so clients can capture AI-driven efficiency value. The model also supports fungible resourcing, enabling reallocation mid-contract to evolving priorities, and faster reinvestment, with savings redirected into innovation. It is underpinned by a hybrid structure with fixed and variable pricing components, supported by use-case–
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