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
Great Britain Leads Europe’s FMCG Inflation as NIQ Launches New Inflation Barometer6.8.2026 09:00:00 CEST | Press release
NIQ (NYSE: NIQ) today launches its new EU5 FMCG Inflation Barometer - a monthly tracker across five Western Europe markets – France, Great Britain, Germany, Italy and Spain – designed to help retailers, manufacturers and the media understand how inflation is evolving across Europe’s largest grocery markets and how shoppers are responding. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806579111/en/ EU5 CPG Inflation slows to +1.1% The first edition of the Barometer reveals that while inflation across Europe’s FMCG sector remains relatively contained overall, significant differences persist between countries. Key findings include: Great Britain recorded the highest FMCG inflation across the EU5 at +2.3%1, above the European average of +1.1%. France and Italy reported the lowest inflation at -0.4% and +0.6% retrospectively, highlighting the uneven inflationary landscape across Europe's major economies. The monthly Barometer
NTT DOCOMO BUSINESS and Chile’s State-owned Copper Company CODELCO Launch a Study and Proof of Concept Aimed at Improving the Efficiency of Remote Copper Mine Operations Using IOWN® APN6.8.2026 06:30:00 CEST | Press release
NTT DOCOMO BUSINESS, Inc. (formerly NTT Communications Corporation) has launched a study and proof of concept jointly with Corporación Nacional del Cobre de Chile (CODELCO) to progress remote operations at CODELCO’s copper mines using an IOWN® All-Photonics Network (APN).1 This initiative is part of a research project commissioned by Japan’s Ministry of Internal Affairs and Communications.2 This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260806845222/en/ Conceptual Diagram of the Demonstration To address operational challenges faced by CODELCO’s copper mines, the initiative will connect a copper mine and a remote operations center—approximately 1,500 km apart—via an IOWN APN. It will assess the feasibility of remotely operating heavy machinery using high-capacity, low-latency communication links, enhancing monitoring operations through high-definition video, and implementing a remote operations model. 1. Background Chile is o
FPT Named an OpenAI Select Partner6.8.2026 02:00:00 CEST | Press release
Global IT corporation FPT today announced that it has been named an OpenAI Select Partner within the OpenAI Partner Network. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260805503787/en/ FPT Named an OpenAI Select Partner The OpenAI Partner Network is a global program for partners to build, sell, and deliver AI solutions with OpenAI. It brings together partners with deep industry expertise, delivery capabilities, and customer relationships while equipping them with resources, enablement, and support to help enterprises adopt OpenAI frontier models and products and turn them into measurable impact. As an OpenAI Select Partner, FPT will continue working with OpenAI to help organizations build, deploy, and scale AI solutions responsibly and effectively. This work will help organizations get more useful work from every token and stronger performance per dollar with GPT‑5.6, while using ChatGPT Work to turn ambitious goals into
U.S. FDA Approves Takeda’s ORZEYFUL™ (oveporexton), the First and Only Medicine to Treat the Underlying Cause of Narcolepsy Type 16.8.2026 00:10:00 CEST | Press release
Adults Taking ORZEYFUL Experienced Significant and Meaningful Improvements Across the Full Range of Symptoms of Narcolepsy Type 1 (NT1) in Clinical Trials Compared to Those on Placebo As a First-in-Class Orexin Treatment, ORZEYFUL has the Potential to Redefine NT1 Care Beyond Individual Symptoms Takeda is Advancing U.S. Launch Preparations and Expects to Make ORZEYFUL Available Following Completion of the Drug Enforcement Administration (DEA) Scheduling Process Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 (OX2R) agonist, for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults.* The persistent 24-hour nature of NT1 is driven by orexin deficiency and can severely impact people’s lives. As a first-in-class orexin treatment, ORZEYFUL is the only medicine indicated in the U.S. to treat the disease holistically rather than individual symptoms. “The FDA approval of OR
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)5.8.2026 22:30:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to fourteen newly hired non-executive employees. The equity awards were granted on August 3, 2026 and consisted of options to purchase an aggregate of 139,355 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 66,300 shares. The options have an exercise price per share equal to $11.25, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restricted
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