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
ARIS Recognized as a Leader in First Gartner® Magic Quadrant™ for Digital Twin of an Organization Platforms, Believes This Reinforces Need for Trusted Governance and Control of Enterprise AI30.7.2026 18:00:00 CEST | Press release
ARIS, the process context platform enabling enterprise AI deployment, today announced its recognition as a Leader in the inaugural Gartner Magic Quadrant for Digital Twin of An Organization (DTO) Platforms – where it believes agentic AI, autonomous workflows, and enterprise governance converge. As enterprises move from AI experimentation to autonomous agent deployment, a critical challenge emerges: how do you safely scale autonomous AI when the enterprise lacks a unified digital twin – a single source of truth for processes, data, governance, and outcomes? Gartner describes the DTO as a dynamic software model that relies on operational and contextual data to understand how an organization operationalizes its business model, connects with its current state, responds to changes, deploys resources, simulates future states and delivers customer value. "Enterprises are rightfully ambitious about agentic AI and autonomous workflows," said Guillaume Bacuvier, CEO of ARIS. "But they're discove
Kingswood Capital Management Raises $4 Billion Across Two Oversubscribed Middle-Market Funds30.7.2026 17:00:00 CEST | Press release
The firm’s fourth institutional fundraise more than doubles its assets under management, reaching over $7 billion Kingswood Capital Management, L.P. (together with its affiliates, “Kingswood”), a Los Angeles-based investment firm focused on the middle-market, today announced the final closing of Kingswood Capital Opportunities Fund IV, L.P. (together with its parallel fund, “Fund IV”), with total capital commitments of $3.1 billion, as well as Kingswood Capital Opportunities Small Cap Fund I, L.P. (together with its parallel fund, “Small Cap Fund I”), with total capital commitments of $900 million. These funds more than double Kingswood’s total assets under management (“AUM”) to over $7 billion. Fund IV represents the fourth institutional fundraise in five years for Kingswood and is more than double the size of Fund III. Both Fund IV and the inaugural Small Cap Fund I were significantly oversubscribed in just five weeks. Fund IV exceeded its initial target of $2.25 billion, while Small
CyrusOne Names John Hatem Chief Executive Officer to Accelerate its Global Digital Infrastructure Strategy30.7.2026 15:30:00 CEST | Press release
Nearly 15-Year Company Veteran and Respected Industry Leader Succeeds Eric Schwartz CyrusOne (the “Company”), a leading global data center owner, developer and operator, today announced the appointment of John Hatem as Chief Executive Officer and a member of the Company’s Board, effective immediately. As part of the Company’s long-term succession planning, Eric Schwartz, who successfully led CyrusOne through a period of significant expansion, is stepping down as CEO and will work together with Hatem to ensure a smooth transition. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730005910/en/ John Hatem Hatem joined CyrusOne in 2011 and has held a series of increasingly senior roles across the business. He most recently served as President, responsible for global sales, global procurement, and design, engineering, and construction in the United States. His deep experience in data center design, development, and operations ha
Mary Kay Releases 2026 Sustainability Report Highlighting Transformative Progress Across Social, Economic, and Environmental Impact Globally30.7.2026 14:03:00 CEST | Press release
Beauty Leader Ranked #8 on Forbes’ 2026 Best Brands For Social Impact List Mary Kay Inc., a leading global beauty company committed to sustainability and women’s empowerment, today released its 2026 Sustainability Report, outlining progress toward its 2030 goals and celebrating the 2025 and latest achievements that continue to drive positive change globally. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730240667/en/ Mary Kay's annual 2026 Sustainability Report highlights the company's decades-long dedication to social, economic, and environmental sustainability - core pillars central to its business strategy and its purpose-driven legacy rooted in Mary Kay's mission of “enriching women’s lives” around the world. (Image Credit: Mary Kay Inc.) The annual report highlights Mary Kay’s decades-long dedication to social, economic, and environmental sustainability - core pillars central to its business strategy and its purpose
INNIO Awarded EcoVadis Platinum Medal for Fifth Consecutive Year30.7.2026 14:00:00 CEST | Press release
INNIO N.V. (Nasdaq: INIO) has been awarded the EcoVadis Platinum Medal, the highest recognition granted by the globally trusted provider of business sustainability ratings. This marks the fifth consecutive year that INNIO has achieved Platinum status since 2022. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260730309718/en/ INNIO N.V. Awarded EcoVadis Platinum Medal for Fifth Consecutive Year In the latest assessment cycle, INNIO further improved its overall EcoVadis score compared to the previous year by introducing additional policies and further strengthening its sustainability management system. “This recognition is a strong validation of our sustainability strategy,” said Marcin Kawa, Vice President Sustainability at INNIO. “Achieving EcoVadis Platinum status for the fifth consecutive year shows that we have consistently delivered on our sustainability commitments and embedded responsible business practices throughout
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