VIFOR-PHARMA
24.6.2021 07:02:13 CEST | Business Wire | Press release
Regulatory News:
Vifor Pharma Group today announced that the phase-IIIb DIAMOND study has been amended with new and clinically relevant endpoints, including a new primary endpoint of efficacy in potassium management in high-risk heart failure patients treated with guideline-recommended doses of renin-angiotensin aldosterone system inhibitor (RAASi). This decision has been made on the recommendation from the independent study Executive Committee and following the significant impact of COVID-19 on recruitment.
Patients with heart failure and chronic kidney disease are among those at the highest risk of severe outcomes of COVID-19 infection. During the pandemic, treatment practices have been adapted to reduce risks of exposure to COVID-19 during hospital visits, disrupting clinical care and impacting the conduct of randomized clinical trials such as the DIAMOND study. This has led to fewer patients enrolled in the trial than anticipated and to a slower incidence of cardio-vascular events.
More than 1,000 patients with heart failure and with hyperkalemia or history of hyperkalemia have already been enrolled in DIAMOND. Following the change of endpoints, study read-out and remaining data collection is expected to be completed in 2021.
Prof. Javed Butler, Principal Investigator for the DIAMOND study, said: “Guidelines give strong recommendation to use RAASi to reduce mortality and morbidity in heart failure patients, but unfortunately patients are often treated with low doses, or not treated at all, because RAASi increase potassium levels, which can cause hyperkalemia. The new primary endpoint allows us to investigate the role of Veltassa® in controlling serum potassium and potentially preventing hyperkalemia in heart failure patients treated with RAASi. This will maximize the scientific utility of the data collected in DIAMOND.”
Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma Group, commented: “We believe that this decision is a responsible approach towards the heart failure patients participating in the trial and towards the need of the medical community to learn from the outcomes of the DIAMOND study. A significant amount of evidence on the use of Veltassa® in combination with RAASi medication has been recorded in DIAMOND. We expect these data to support an effective management of hyperkalemia in patients on RAASi therapy with Veltassa® and look forward to sharing this data during spring 2022 at a major conference.”
Vifor Pharma continues to support several data generation programs with the ongoing phase-IV PLATINUM study and the CARE-HK global study platform to drive evidence-based care using Veltassa® in chronic kidney disease and heart failure patients.
Conference call:
Vifor Pharma will host a conference call today, 24 June 2021 at 10:30 am (CET).
Access to conference call → link
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 DIAMOND
This global, multicenter, double-blind, placebo controlled DIAMOND study was designed to evaluate the potential role of Veltassa® in enabling patients with, or at high risk of, hyperkalemia to remain on RAASi therapy. The previous primary endpoint of the study was the time to first occurrence of cardiovascular death or cardiovascular hospitalization. On recommendation of the independent study Executive Committee and due to COVID-19 impact on recruitment, the primary endpoint has been changed to investigate the role of Veltassa® in controlling serum potassium and potentially prevent hyperkalemia in heart failure patients treated with RAASi. More than 1,000 patients with hyperkalemia or history of hyperkalemia, who are therefore not able to use guideline-recommended doses of RAASi, were enrolled in the study.
About hyperkalemia
Hyperkalemia is a serious condition characterized by elevated levels of potassium in the blood. Patients with chronic kidney disease and heart failure, especially those treated with RAASi, are at particular risk of developing the condition. Studies have shown Veltassa® enables patients to remain on RAASi therapy by effectively managing their chronic hyperkalemia.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210623005811/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
VELOCIFERO Takes Action Against Counterfeiting in China13.11.2026 17:32:00 CET | Press release
White s.r.o., exclusive owner of the VELOCIFERO brand, takes action in China to protect its intellectual property rights. Initial measures in Chongqing and Taizhou have already resulted in the seizure of vehicles alleged to be counterfeit. VELOCIFERO is taking action against counterfeiting in China. White s.r.o., the exclusive owner of the VELOCIFERO brand and its related intellectual property rights, has launched decisive measures to protect its creative and industrial assets. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261113797570/en/ Photo courtesy of White s.r.o. “Vehicle sealed in Chongqing as part of actions undertaken to protect VELOCIFERO’s intellectual property rights.” The matter originated in June 2026 when, according to the company’s complaint, computers were removed from the technical office of Taizhou Siweiluo, the company appointed to manufacture VELOCIFERO products. White s.r.o. subsequently became aware
LangChain Raises $300M to Enable Every Company to Own Their Intelligence13.11.2026 16:53:00 CET | Press release
CapitalG leads Series C funding round at a $3B valuation to advance LangChain's agent engineering platform LangChain today announced it has raised $300 million in new funding at a $3 billion valuation, bringing total funding to date to $460 million. The round was led by existing investor CapitalG, with significant participation from new investors GIC and DFJ Growth and existing investors IVP and Sapphire Ventures. LangChain is advancing its mission to help every company own its intelligence. As agents transform the economy, companies are building domain-specific agents differentiated by their knowledge, data, and user experience. These agents will power new products and transform internal company operations, creating lasting competitive advantages for the companies that control them. "Agents are going to transform how companies operate and the products they deliver. The companies that control these systems will build lasting competitive advantages," said Harrison Chase, Co-Founder and
Kinaxis Named a Leader in Five 2026 IDC MarketScapes for Worldwide Supply Chain Planning13.11.2026 13:00:00 CET | Press release
Maestro delivers concurrent planning on a single platform across discrete, process, consumer packaged goods and life sciences Kinaxis® Inc. (TSX:KXS), a global leader in end-to-end supply chain planning and orchestration, today announced it has been named a Leader in five 2026 IDC MarketScape vendor assessments for worldwide supply chain planning. The recognition spans the overall market and four industries - discrete industries, process industries, consumer packaged goods and life sciences industries - all served by a single platform, Kinaxis Maestro®, the company's AI-powered supply chain orchestration platform. "Supply chain leaders don't need a better forecast once a month. They need to know what changed this morning, what it means across the business, and what to do about it," said Andrew Bell, Chief Product Officer of Kinaxis. "I believe being named a Leader across five IDC MarketScape vendor assessments, in industries that plan in very different ways, shows that a single concurr
SBC Medical Announces Capital and Business Alliance with NeuroBrain Dynamics to Advance Clinic Profitability Through Medical AI13.11.2026 12:30:00 CET | Press release
Companies to co-develop six medical AI solutions targeting revenue expansion and cost reduction; SBC Medical secures priority sales rights in Japan and South Korea and targets B2B expansion across Asia SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“The Company” or “SBC Medical”), a Medical Services Organization (MSO) providing management support across a wide range of healthcare fields, today announced a strategic capital and business alliance agreement with NeuroBrain Dynamics Inc. (“NBD”), a Taipei-based company dedicated to enterprise generative AI solutions. As part of the agreement executed on November 13, 2026, SBC Medical has made a minority equity investment in NBD. Through this alliance, SBC Medical plans to introduce two complementary suites of generative AI solutions across its network of 287 clinics in Japan and overseas*: “revenue-growth AI,” to elevate average revenue per visit and customer retention through personalized customer guidance, and “cost-reduction AI,
SBC Medical Group Holdings Reports Third Quarter 2026 Financial Results13.11.2026 12:30:00 CET | Press release
Revenue Up 35%, Net Income Attributable to SBC Medical Up 22%, and Adjusted EBITDA1 Up 66% Year-over-Year; Net Income Margin of 27% and Adjusted EBITDA Margin of 47% — Previously Announced Service Fee Revisions and New Clinic Openings Contribute to Revenue Growth and Operating Margin Improvement SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“SBC Medical” or the “Company”), a Medical Services Organization (MSO) providing management support across a wide range of healthcare fields to medical institutions in Japan and abroad, today announced its consolidated financial results for the third quarter of fiscal year 2026 (the three months ended September 30, 2026) and the three cumulative quarters of fiscal year 2026 (the nine months ended September 30, 2026). Third Quarter 2026 Financial Highlights Total revenues were $59 million, up 35% year-over-year. Income from operations was $26 million, up 66% year-over-year, with an operating margin of 45%. Net income attributable to SBC Medi
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