Kapruvia® approved by European Commission for the treatment of moderate-to-severe pruritus in hemodialysis patients
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220427005801/en/
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the European Commission has granted marketing authorization to Kapruvia® (difelikefalin) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adult hemodialysis patients. The marketing authorization, which approves Kapruvia® for use in all member states of the European Union plus Iceland, Liechtenstein and Norway, follows the U.S. Food and Drug Administration (FDA) approval of KORSUVA™ (difelikefalin) injection in August 2021 for the same indication. Kapruvia® will be the first therapy available in Europe for the treatment of CKD-associated pruritus in hemodialysis patients.
“We are very excited about the European Commission’s approval of Kapruvia®, marking an important milestone on our journey to advance and fundamentally change the treatment paradigm for people living with the severe burden of pruritus associated with chronic kidney disease,” said Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. “We look forward to bringing this first-in-class therapy to patients in Europe, with launch in first markets expected in the second half of 2022.”
“The European Commission’s approval of Kapruvia® provides a much-needed therapy to hemodialysis patients in Europe who suffer from pruritus,” said Dr. Joana Goncalves, Chief Medical Officer of Cara Therapeutics. “We are excited to bring an innovative drug to physicians to help change the way pruritus is managed. We continue to work with our commercial partner VFMCRP, to fill a significant unmet medical need among CKD patients with pruritus in both the U.S. and Europe.”
The approval in Europe is based on pivotal clinical data from two phase-III trials, KALM-1 and KALM-2, as well as supportive data from an additional 32 clinical studies. These studies showed that treatment with Kapruvia® resulted in clinically meaningful improvements in pruritus severity and in pruritus-related quality of life components and was found to be generally well tolerated in patients with moderate-to-severe CKD-associated pruritus.
About Vifor Pharma Group
Vifor Pharma Group is a global pharmaceuticals company. It aims to become the global leader in iron deficiency and nephrology. The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. Vifor Pharma Group strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and includes the companies: Vifor Pharma, Sanifit Therapeutics, 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
For more information, please visit viforpharma.com.
About Cara Therapeutics
Cara Therapeutics is an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company’s novel KORSUVA™ (difelikefalin) injection is the first and only FDA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. The Company is developing an oral formulation of difelikefalin and has initiated Phase 3 programs for the treatment of pruritus in patients with non-dialysis dependent advanced chronic kidney disease and atopic dermatitis. Phase 2 trials of oral difelikefalin are ongoing in primary biliary cholangitis and notalgia paresthetica patients with moderate-to-severe pruritus. For more information, visit www.CaraTherapeutics.com and follow the company on Twitter, LinkedIn and Instagram.
About Chronic Kidney Disease-associated Pruritus
CKD-associated pruritus 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 Data from the ITCH National Registry Study showed that among those with pruritus, approximately 59%4 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-associated pruritus is also an independent predictor of mortality and the risk for hospitalization among hemodialysis patients.
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 the launch of difelikefalin solution for injection in Europe 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 2021 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.
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/20220427005801/en/
Global Head Corporate Communications
+41 79 957 96 73
Cara Therapeutics contacts:
Iris Francesconi, PhD
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
Tezos Foundation and Artist Misan Harriman Unveil First Works in Permanent Art Collection9.6.2023 18:42:00 EEST | Press release
Today, the Tezos Foundation, which promotes development on the Tezos blockchain, and Misan Harriman, the world-renowned photographer and activist, announced the first presentation of the Tezos Foundation Permanent Art Collection to celebrate artists and creators in the Tezos ecosystem. These works will be on display in a Digital Art Gallery, to be revealed on June 16 on the Collection’s website for public viewing. The initial presentation is just a fraction of the overall collection of over 2,000 works acquired between May 2022-2023 with a $1.2M USD endowment from the Tezos Foundation to Misan Harriman. Spearheaded by the Tezos Foundation and driven by Harriman, the initiative reflects the diversity of the digital art community in the Tezos ecosystem and showcases works by artists who span five continents and more than two dozen nationalities. The first online gallery is separated into three rooms - Who We Are, What We Become, and Tracks of Existence - which highlight important themes
Vertex Presents Data Demonstrating Significant Benefits of Long-Term Treatment With CFTR Modulators at the European Cystic Fibrosis Conference9.6.2023 18:00:00 EEST | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that 12 scientific abstracts on the company’s portfolio of cystic fibrosis (CF) medicines were presented at this year’s European Cystic Fibrosis Society's (ECFS) 46th European Cystic Fibrosis Conference held June 7-10, 2023, in Vienna, Austria. Together, the data presented show the long-term benefits of treatment with CFTR modulators as well as the importance of treating the underlying cause of CF as early in life as possible. Key data presented at this year’s conference are highlighted below. Vertex presented an interim analysis (IA) of a registry-based study of real-world data collected from people with CF and treated with TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor), also known in the European Union and in the U.K. as KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor, including over 16,000 people with CF from the Cystic Fibrosis Foundation Patient Registry (CFFPR) and nearly 3,00
Galtronics Improves Attendee Experience at NFL Stadiums and MLB Ballparks Nationwide9.6.2023 12:00:00 EEST | Press release
Galtronics, the company that combines collaboration with technology innovation to solve the world’s most complex wireless connectivity challenges, today announced distributed antenna system (DAS) upgrades across four major stadiums. Galtronics’ antennas will be deployed at Arrowhead Stadium, home of the defending Super Bowl Champion Kansas City Chiefs; Ford Field, home of the Detroit Lions; Bank of America Stadium, home of the Carolina Panthers; and T-Mobile Park, home of the Seattle Mariners. The recent upgrades will provide increased sectorization to drive higher levels of capacity and data speeds, allowing fans to stream other sporting events, keep up with fantasy team stats or share live event interaction over social platforms. In total, Galtronics is providing 705 antennas across the three stadiums and ballpark. The C-Band antenna upgrades range from HyperFlat (Ceiling mount Omni DAS Antenna), Small Panel antennas and a combination of 30x30 and 30x60 Stadium Panel Antennas. They w
Superior Graphite to Build 24.000 Ton Per Annum Active Anode Material Capacity at 1/3 the CapEx Cost9.6.2023 11:38:00 EEST | Press release
Superior Graphite, a leading producer of graphite, plans to construct a USD180 million anode materials facility to meet the accelerating demand for EV’s and energy storage in the North American and European markets. The company's state-of-the-art Anode Active Material (AAM) enables and accelerates the energy transition. The main facility will be in Hopkinsville, Kentucky, with additional capacity in Sundsvall, Sweden. Superior Graphite's innovative production technology and established operations at these locations result in a continuous production process, significantly reducing capital requirements and operational costs. "Our technology and product brands are trusted by high-volume customers worldwide. Our unique technology uses approximately 70% less electricity, labor, and space compared to traditional production processes. The carbon footprint is reduced by nearly 85%, and the cost savings for EV companies are substantial," says Ed Carney, CEO of Superior Graphite. Meeting the IRA
Mega Refining and Petrochemical Plant Selects Hytera as Provider of Professional Communications System9.6.2023 11:08:00 EEST | Press release
Hytera, a global leading provider of professional communication technologies and solutions, has been selected as the supplier of professional communications solution for the Yulong Island Refining and Petrochemical Integration Project in Shandong Province, China. Hytera won this public tender with its advanced professional digital trunking (PDT) infrastructure, control and dispatch system , network management system (NMS), digital voice recording system (DVRS), and intrinsically safe (IS) PDT two-way radios . This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230609005125/en/ PD790Ex Intrinsically Safe PDT Two-way Radio (Graphic: Business Wire) The Yulong project is the largest refining and petrochemical facility being constructed in China. With a projected overall production capacity of 40 million tons per year, this plant is a strategic venture aimed at driving economic growth, enhancing energy production capabilities, and pro
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