Business Wire

Vifor Pharma and Cara Therapeutics announce U.S. FDA approval of KORSUVA™ injection for the treatment of moderate-to-severe pruritus in hemodialysis patients

Share

Regulatory News:

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210823005635/en/

Vifor Pharma and Cara Therapeutics (Nasdaq:CARA) today announced that the U.S. Food and Drug Administration (FDA) has approved KORSUVA™ (difelikefalin) for injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. KORSUVA™ injection is a first-in-class kappa opioid receptor (KOR) agonist that targets the body’s peripheral nervous system. The KORSUVA™ injection New Drug Application (NDA) received Priority Review by the FDA, which is granted to therapies that, if approved, would offer significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.

“We are very excited about the FDA approval of KORSUVA™ injection,” said Abbas Hussain, Chief Executive Officer of Vifor Pharma. “There is a significant unmet medical need for a targeted therapy, and we believe that KORSUVA™ injection can fundamentally change the treatment paradigm for adult CKD-aP patients undergoing dialysis. We are committed to bringing this first-in-class medicine to U.S. hemodialysis patients as fast as possible, together with our partner Cara Therapeutics.”

“The FDA approval of KORSUVA™ injection is a transformational milestone for Cara and a significant advancement for the substantial number of adult hemodialysis patients suffering from moderate-to-severe pruritus,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “We look forward to working closely with our commercial partner, Vifor Pharma, to launch KORSUVA™ injection in the U.S. in the coming months. We extend our deepest gratitude to the patients who participated in our KALM-1 and KALM-2 clinical trials, the study investigators, and especially our employees, as their commitment through over 10 years of collective effort made this important milestone possible.”

“We are pleased to see that KORSUVA™ injection has received FDA approval as the first treatment option approved for moderate to severe pruritus in adult CKD patients on hemodialysis,” commented Dr. Frank Maddux, Global Chief Medical Officer of Fresenius Medical Care. “Participating in the robust clinical trial program we have learned that KORSUVA™ injection represents an effective treatment option. We have seen substantial improvement in symptoms and meaningful relief for people suffering from severe and debilitating itch.”

This approval is based on the New Drug Application filing that was 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. KORSUVA™ injection was found to be generally well tolerated.

Vifor Pharma and Cara have agreed to an exclusive license to commercialize KORSUVA™ injection in the United States. That agreement features a Cara 60%, Vifor Pharma 40% profit-sharing arrangement in non-Fresenius Medical Care clinics in the U.S. Under a previous agreement, Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics have agreed to market KORSUVA™ injection to Fresenius Medical Care North America dialysis clinics in the U.S. under a Cara 50%, Vifor Pharma 50% profit-sharing arrangement.

Vifor Pharma and Cara Therapeutics are in the process of submitting the required documentation to the U.S. Centers for Medicare and Medicaid Services (CMS) to ensure timely reimbursement and patient access to KORSUVA™ injection. Vifor Pharma expects to begin to market KORSUVA™ injection in Q1 2022 with reimbursement expected in H1 2022, subject to CMS timelines.

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 completed Phase 2 trials for the treatment of pruritus in patients with CKD and AD and is currently in Phase 2 trials in PBC and NP patients with moderate-to-severe pruritus.

About KORSUVA™ injection
KORSUVA™ injection is a kappa opioid receptor agonist developed in Cara laboratories and indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD). KORSUVA injection is not a federally controlled substance.

Breakthrough Therapy Designation was received from the FDA for KORSUVA™ injection for the treatment of CKD-aP in HD patients and the New Drug Application was evaluated by the FDA with Priority Review.

Important Safety Information

Warnings and Precautions
Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances: These adverse reactions, including falls, have occurred in patients taking KORSUVA™ and may subside with continued treatment. Concomitant use of centrally acting depressant medications, sedating antihistamines, and opioid analgesics may increase the likelihood of these adverse reactions and should be used with caution during treatment with KORSUVA™.

Risk of Driving and Operating Machinery: Dizziness, somnolence, and mental status changes have occurred in patients taking KORSUVA™. KORSUVA™ may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car and operating machinery. Advise patients not to drive or operate dangerous machinery until the effect of KORSUVA™ on their ability to do so is known.

Adverse Reactions
The most common adverse reactions (incidence ≥2% and ≥1% higher than placebo) were diarrhea (9.0%), dizziness (6.8%), nausea (6.6%), gait disturbances, including falls (6.6%), hyperkalemia (4.7%), headache (4.5%), somnolence (4.2%), and mental status changes (3.3%).

Use in Specific Populations
Severe Hepatic Impairment: The influence of severe hepatic impairment on the pharmacokinetics of KORSUVA™ in subjects undergoing hemodialysis (HD) has not been evaluated; therefore, use of KORSUVA ™in this population is not recommended. Geriatric Use: The incidence of somnolence was higher in KORSUVA™-treated subjects aged 65 years and older (7.0%) than in KORSUVA™-treated subjects less than 65 years of age (2.8%). The incidence was comparable in both placebo age groups (3.0% and 2.1%, respectively).

Indication
KORSUVA™ is indicated for the treatment of moderate to severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).

Limitation of Use: KORSUVA™ has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.

Please see KORSUVA™ injection full Prescribing Information at www.korsuva.com.

About Chronic Kidney Disease-associated Pruritus
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.

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 launch of KORSUVA™ injection, the potential timeline for reimbursement and the potential of KORSUVA™ 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.

Contact 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:
Media
Claire LaCagnina
6 Degrees
315-765-1462
clacagnina@6degreespr.com

Investors
Janhavi Mohite
Stern Investor Relations, Inc.
212-363-1200
janhavi.mohite@sternir.com

About Business Wire

Business Wire
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

Leaders in Cloud Adoption Approach Cloud Differently and Achieve 10x Greater ROI, Says Research by Wipro FullStride Cloud Services22.9.2021 18:24:00 CEST | Press release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today released a report indicating that leaders in cloud adoption approach their cloud journey differently than beginners, enabling them to achieve a 10x greater annualized return on investment. Wipro’s report, “Making Business Thrive: A Cloud Leader Roadmap for Achieving 10x ROI,” outlines these best practices for enterprises beginning their cloud journey or seeking to accelerate their results. The report also identifies dozens of key cloud-adoption metrics for multiple industries and countries. Wipro FullStride Cloud Services developed the report based on a survey of 1,300 global C-level executives and key decision-makers from 11 industries and six countries (see “Methodology” below). Wipro considered leaders to be the top 19% of respondents based on cloud maturity, while beginners represented the lowest 32%; this was not based on revenue. Thi

Nathan's Famous Continues International Expansion with European Push to Offer Hot Dogs in France22.9.2021 17:57:00 CEST | Press release

Nathan's Famous, Inc., the American tradition serving New York favorites for more than 100 years, announces a new collaboration with Tommy's Diner, a 50's throwback American diner based in France, to offer its hot dogs in all locations across the country, making it the first time Nathan's Famous is served in France. This relationship continues Nathan's Famous growth in Europe and beyond. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005823/en/ Nathan's Famous Menu. (Photo: Business Wire) "Nathan's Famous is known the world over, which is why we've had such great success in recent years growing in the Middle East, Asia, and Great Britain," states James Walker, Senior Vice President, Restaurants. "This new relationship with Tommy's is a big step for us as we look to see that growth spread throughout Europe, and we're excited that they are our first French outpost and will be one of the first internationally to have our

IHMA Opens Microbiology Reference Laboratory in Shanghai, China to Further Support Global Anti-Infective Product Discovery and Development22.9.2021 16:30:00 CEST | Press release

IHMA has opened a microbiology reference laboratory in Shanghai, China in February of 2021. This facility will join IHMA locations in the USA, Switzerland and India to allow the company to provide more robust global support for anti-infective product discovery and development. The China facility will provide microbiology testing to support profiling of new antimicrobial products, antimicrobial resistance surveillance, molecular characterization of resistant organisms, and serve as a central laboratory for clinical trials conducted in China. “We have been working for almost 30 years to maximize our in vitro support for clients who are developing anti-infective products globally. Our facility in China will greatly enhance that effort and support clients wishing to conduct studies in this important market,” said Jack L. Johnson, President/CEO of IHMA. About IHMA: As the leading global microbiology service provider to the biopharmaceutical industry, IHMA utilizes its extensive laboratory a

Workiva Named a Leader Among Governance, Risk, and Compliance Platforms by Independent Research Firm22.9.2021 16:24:00 CEST | Press release

Workiva Inc. (NYSE:WK), today announced that it was classified as a Leader in The Forrester Wave™: Governance, Risk, and Compliance (GRC) Platforms Q3 2021 report. The company’s connected cloud platform enables collaboration and deep integration into existing systems and workstreams to simplify audit, risk and compliance, operational, financial, and non-financial reporting for companies across the globe. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005704/en/ Workiva Named a Leader Among Governance, Risk, and Compliance Platforms by Independent Research Firm (Graphic: Business Wire) Evaluating GRC solutions against 25 criteria, Forrester identified 15 vendors available today, and proceeded to research, analyze, and score them. The report summarizes how each provider measures up, and ranks their solutions based on how well they satisfy the current and future needs of audit, risk, and compliance professionals. Workiva

The Scottish National Blood Transfusion Service (SNBTS) to Deploy Biolog-id Smart Storage RFID Kits Nationwide22.9.2021 15:50:00 CEST | Press release

The Scottish National Blood Transfusion Service (SNBTS) – the specialist provider of transfusion medicine in Scotland – will implement the biolog-id blood inventory devices to optimize the management of its blood products across the country. Through this deployment, biolog-id’s cutting-edge technology will streamline the complex inventory and distribution processes of the red blood cells to distant sites, enhancing the visibility and management of those lifesaving products between the Scottish blood centre and each remote blood bank. Designed for healthcare professionals specialized in the transfusion field, the Biolog Transfusion Solution combines RFID enabled devices powered by a proprietary IT engine and electronic labels. Biolog-id’s contactless devices are integrated into SNBTS’ IT transfusion management solution (MAK-SYSTEM – e-TRACELINE), offering real-time visibility of each component at each step of the supply chain. The corner-stone devices of this solution are the RFID Smart

Let’s Build a Digital Future Together: Join us at Dahua Partner Day 2021!22.9.2021 15:45:00 CEST | Press release

Dahua Technology, a world-leading video-centric smart IoT solution and service provider, will hold its 2nd online Dahua Technology Partner Day on October 13th - 14th with the theme “Building a digital future”. Adhering to its strategy of open cooperation, Dahua Technology is committed to creating a win-win ecosystem with leading technology partners around the world. This year, Dahua Technology will join hands with its 22 global partners to discuss interoperability, share industry trends, and explore the future of digitalization and intelligence together. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210922005395/en/ (Photo: Business Wire) “We are excited to host our second virtual technology partner day. Technologies have evolved fast in the past year, and the needs of digitization and diversified challenges facing different industries today are driving the integration of security companies,” says Mr. Jiaqi Gao, Overseas Ma

Takeda Selects Four New Partners for Annual Global Corporate Social Responsibility (CSR) Program to Help Strengthen Health Systems in Low- and Middle-Income Countries22.9.2021 15:30:00 CEST | Press release

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced the addition of four partnerships to its Global Corporate Social Responsibility (CSR) Program, which makes long-term commitments to strengthen health systems and improve access to healthcare for all in developing and emerging countries. As part of an annual decision-making process, Takeda employees worldwide voted to add IntraHealth International, Jhpiego, Pathfinder International and the World Food Programme(WFP) as new partners for the Global CSR Program, which now supports 20 programs in 72 countries. Takeda’s commitments to these new partners in FY2021 include: JPY 953 million to IntraHealth International to work with 12 private schools in Mali, Senegal and Niger to increase the number of qualified, trained nurses who can serve rural communities facing a critical shortage of health workers in these countries. Over the next five years, the project will help private schools partner with the public se

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