Vifor Pharma’s Phase-II AMBER Study Meets Primary Endpoint
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190510005469/en/
Vifor Pharma today announced results from the phase-II AMBER study which demonstrated that a significantly higher proportion of patients with resistant hypertension (RHTN) and chronic kidney disease (CKD) taking Veltassa® (patiromer) remained on spironolactone therapy compared to patients taking placebo at week 12. Veltassa® was shown to enable persistent use of spironolactone by controlling blood potassium levels. The data were presented at the 2019 National Kidney Foundation (NKF) Congress in Boston, MA on 10 May 2019.
The study achieved statistical significance of its pre-specified primary endpoint by demonstrating that a significantly higher proportion of patients taking Veltassa® remained on spironolactone therapy through 12 weeks of treatment versus placebo with concomitant spironolactone in patients with RHTN and CKD (86% vs. 66%, p < .0001, respectively). Safety results are consistent with existing Veltassa® data, with no new safety issues identified.
“Despite the efficacy of spironolactone in patients with RHTN, its use has never been studied in those who also have CKD due to the occurrence or risk of developing hyperkalaemia,” said Dr. Rajiv Agarwal, Professor of Medicine, Indiana University School of Medicine. “The AMBER data suggest that patients treated with patiromer may be more likely to stay on spironolactone therapy, a life-saving medicine for those with RHTN.”
Spironolactone, a renin-angiotensin aldosterone system inhibitor (RAASi), is a key component in the recommended treatment guidelines for patients with resistant hypertension1,2. However, it is challenging for many patients to stay on spironolactone treatment because it can further increase the risk of hyperkalaemia (elevated blood potassium levels), a condition that can cause abnormal heart rhythms and even sudden death3.
“We are pleased with the AMBER study results and hope these data will support better adherence to guideline-directed treatment for patients with resistant hypertension and chronic kidney disease,” said Thierry Teil, Chief Medical Officer of Vifor Pharma. “We look forward to partnering with the community to further validate and explore the promise of Veltassa® in fulfilling a clear unmet need among a complex patient population.”
AMBER is A RandoMized, Double-Blind, Placebo-controlled, Parallel Group Study of Patiromer for the Enablement of Spironolactone Use for Blood PrEssure Control in Patients with Resistant Hypertension and Chronic Kidney Disease: Evaluation of Safety and Efficacy. Approximately 290 patients at 60 sites in the United States, South Africa, the United Kingdom, France, Germany, Croatia, Hungary, Georgia, and Ukraine were enrolled in the study. The primary endpoint was the percentage of subjects remaining on spironolactone at week 12 compared between treatment groups (spironolactone and patiromer versus spironolactone and placebo).
Approximately 73 percent of advanced CKD and 40 percent of chronic heart failure (HF) patients may be at risk of elevated blood potassium levels4. Hyperkalaemia can cause abnormal heart rhythms and even sudden death. There are often no warning signs, meaning a person can unknowingly experience spikes in potassium levels recurrently and be at risk for these cardiac events. Some medicines that are often prescribed to people with CKD and HF to help delay progression of their underlying disease and reduce mortality can cause hyperkalaemia as a side effect. These may include RAASi such as angiotensin receptor blockers (ARBs), aldosterone antagonists (AAs) and angiotensin-converting-enzyme (ACE) inhibitors as well as angiotensin II receptor/neprilysin inhibitors (ARNI).
Veltassa® is a sodium-free potassium binder approved for the treatment of hyperkalaemia. Veltassa® should not replace emergency treatment for life-threatening hyperkalaemia. Made in powder form consisting of smooth, spherical beads, Veltassa® is mixed with water and taken once a day with food. Veltassa® is not absorbed and acts within the gastrointestinal tract. It binds to potassium in exchange for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process.
Important Safety Information about Veltassa ® in the United States
Veltassa® is contraindicated in patients with a history of a hypersensitivity reaction to Veltassa® or any of its components.
Worsening of Gastrointestinal Motility
Use of Veltassa® should be avoided in patients with severe constipation, bowel obstruction or impaction, including abnormal post-operative bowel motility disorders, because Veltassa® may be ineffective and may worsen gastrointestinal conditions. Patients with a history of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders were not included in clinical studies.
Veltassa® binds to magnesium in the colon, which can lead to hypomagnesemia. In clinical studies, hypomagnesemia was reported as an adverse reaction in 5.3 percent of patients treated with Veltassa®. Approximately 9 percent of patients in clinical trials developed hypomagnesemia with a serum magnesium value <1.4 mg/dL. Doctors should monitor serum magnesium and consider magnesium supplementation in patients who develop low serum magnesium levels.
The most common adverse reactions (incidence ≥2 percent) are constipation, hypomagnesemia, diarrhea, nausea, abdominal discomfort and flatulence. Mild to moderate hypersensitivity reactions were reported in 0.3 percent of patients treated with Veltassa® and included edema of the lips.
For Veltassa®’s full Prescribing Information, please visit https://www.veltassa.com/pi.pdf.
Vifor Pharma Group is a global pharmaceuticals company headquartered in Switzerland. It aims to become the global leader in iron deficiency, nephrology and cardio-renal therapies. The company is the 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; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); Relypsa; and OM Pharma. Vifor Pharma Group is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348). For more information, please visit www.viforpharma.com.
Relypsa, Inc., a Vifor Pharma Group company, is a biopharmaceutical company focused on the development and commercialisation of late-stage medicines in the iron deficiency, nephrology and cardio-renal therapeutic areas. Relypsa is committed to delivering innovative therapies and improving the lives of patients with serious and life-threatening conditions that are often overlooked and undertreated. The company's first medicine, Veltassa® (patiromer) for oral suspension, was approved by the U.S. FDA in October 2015, making it the first approved medicine for the treatment of hyperkalaemia in more than 50 years. More information is available at www.relypsa.com.
1 Yancy C et al. American Heart Association. Guideline for the Management of Heart Failure. August 2017. Accessible via http://www.ksw-gtg.com/hfguidelines/pdfs/HFTreatmentHypertensionHFrEF.pdf.
2 Ponikowski P et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Eur Heart J. 2016;37:2129-2200.
3 Rastegar A, Soleimani M. Hypokalaemia and hyperkalaemia. Postgrad Med J. 2001;77:759-764.
4 Rosano GCM, et al. Expert consensus document on the management of hyperkalaemia in patients with cardiovascular disease treated with renin angiotensin aldosterone system inhibitors: coordinated by the Working Group on Cardiovascular Pharmacotherapy of the European Society of Cardiology.Eur Heart J 2018;4:180-188.
Media Relations (excl. US)
Head of Corporate Communications
+41 58 851 80 87
Media Relations (US)
Director of U.S Communications Relypsa
Tel.: +1 650 421 9532
Head of Investor Relations
+41 58 851 66 90
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
Resolve Acquires FixStream for $24M USD to Deliver Game-Changing Combination of AIOps and Advanced Automation in a Unified Platform20.8.2019 08:00:00 CEST | Press release
Resolve Systems®, the leading IT automation and orchestration platform, today announced the acquisition of FixStream, a pioneer in AIOps. The acquisition, expected to close by the end of September, will enable Resolve to offer the most robust IT automation platform available on the market by combining artificial intelligence insights into dynamic, hybrid IT environments with powerful automation capabilities that are purpose-built for the complexity of modern enterprises. The unified platform will handle a wide array of IT operations – from AI-driven infrastructure mapping, operational data correlation, and predictive analytics to intelligently automating cross-domain actions based on those findings. This will enable customers to significantly improve infrastructure performance, reduce mean time to resolution (MTTR), increase IT operations efficiency, reduce alarm noise, and proactively and intelligently allocate resources for critical business services. With 7x revenue growth over the
Wipro Collaborates with IISc for Advanced Research and Innovation in Autonomous Systems, Robotics and 5G20.8.2019 07:27:00 CEST | Press release
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced a strategic partnership with the Indian Institute of Science (IISc), India’s premier public establishment for research and higher education in science and engineering, to conduct advanced applied research in autonomous systems, robotics and 5G space. The two organizations have jointly set up the Wipro IISc Research and Innovation Network (WIRIN), a hybrid industry academia collaboration unit, which will drive idea discovery, research and innovation in technology and product design. A group of senior professors and research staff from IISc and engineers, developers, architects and researchers from the autonomous systems, robotics and 5G domains at Wipro will constitute the team at WIRIN. They will focus on the research and development of cutting-edge technologies in Artificial Intelligence, Machine Learning, Visual Computing, Huma
Misinformation, Lack of Access and Confusion Hamper the Ability of Smokers Who Don’t Quit to Consider Better Alternatives, a New International Study from PMI Shows20.8.2019 04:02:00 CEST | Press release
Philip Morris International Inc. (PMI) (NYSE:PM) today released a white paper titled “Unsmoke: Clearing the Way for Change” based on findings from a major international study conducted for the company by independent research firm Povaddo. There is no question that, while the best choice is to quit cigarettes and nicotine altogether, the reality is that many people don’t. The survey—conducted in 13 countries among adults aged 21 to 74—forms the basis of the paper’s exploration around two core themes: the impact of smoking on personal relationships and the lack of information available about smoke-free products. It reveals some of the barriers that might be preventing smokers from considering smoke-free alternatives over continued smoking. “There is currently a tremendous amount of misinformation circulating about smoke-free products, and this is causing confusion. It is one of the biggest hurdles the world faces in becoming smoke-free,” said Jacek Olczak, chief operating officer at PMI.
The We Company Q2 2019 Financial Results Conference Call19.8.2019 18:56:00 CEST | Press release
WeWork Companies LLC (the “Company”), with respect to its 7.875% Senior Notes due 2025 (the “Senior Notes”), will hold a conference call on Monday, August 26, 2019, at 12:00 P.M. Eastern Time for the benefit of certain qualified participants in order to discuss the Company’s financial results for the second quarter of 2019. Current holders and beneficial owners of the Senior Notes, bona fide prospective purchasers of the Senior Notes who are qualified institutional buyers (as defined in Rule 144A under the Securities Act of 1933) or non-U.S. persons (as defined in Regulation S under the Securities Act of 1933), securities analysts, and market-making financial institutions may gain access to the call information for the conference call by registering on the Company’s secure website at investors.wework.com. Additional information about the call (including dial-in number) will be provided on the secure website. Parties requesting access to the Company’s secure website will be required to
BAI Announces 2019 Global Innovation Award Finalists19.8.2019 17:50:00 CEST | Press release
BAI announced the finalists for the 2019 BAI Global Innovation Awards, the industry’s most prestigious awards program that celebrates transformative solutions in the financial services industry worldwide. Now in its ninth year, the BAI Global Innovation Awards recognizes leading financial services organizations on a global scale. Through hundreds of applications, the Innovation Circle, a panel of global financial services innovation leaders who thoroughly review each application, determined the top submissions. The judges weigh each innovation on originality and impact on consumers and the industry. This year’s finalists showcase what leading financial services innovators in all regions of the world are doing to deliver new value to customers and employees, as well as improve efficiencies and profitability for their organizations. The 2019 BAI Global Innovation Awards finalists are: Best Application of Advanced Technology in a Product or Service Emirates NBD, Dubai, United Arab Emirate
Rimini Street Statement on U.S. Appeals Court Ruling19.8.2019 13:00:00 CEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today issued the following statement in response to the August 16, 2019 ruling by the U.S. Ninth Circuit Court of Appeals in the Oracle v. Rimini Street litigation which was filed in January 2010, went to trial in 2015, and has been on appeal since: “We are pleased that the Appeals Court again corrected legal errors in the District Court’s post-trial orders, adding to the Appeals Court’s and Supreme Court’s prior reversals in this case and refunds from Oracle totaling over $34 million. Oracle lost 23 of 24 claims it originally pursued against Rimini Street in this case, with the jury finding that Rimini Street engaged in “innocent infringement” on the remaining claim. Rimini Street had voluntarily stopped using the legacy processes that were found to be infringing before the 2015 trial