Business Wire

DIAMOND trial: Veltassa ® enables patients to achieve long-term potassium control and optimized RAASi therapy

Share

Regulatory News:

AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR

Vifor Pharma today announced full results from its phase-IIIb DIAMOND trial showing that Veltassa® allowed patients to achieve long-term potassium control, reduced the risk of recurrent hyperkalemia and prolonged optimized and guideline recommended renin-angiotensin aldosterone system inhibitor (RAASi) therapy. The findings were presented at the 71st Annual Scientific Session & Expo of the American College of Cardiology (ACC) in Washington D.C., U.S.

DIAMOND is the largest interventional study to date for potassium binders investigating the benefits of potassium control in more than 1,000 patients. The trial met its primary and all five key secondary endpoints.

  • Treatment with Veltassa® lowered the risk of hyperkalemia events by 37%
  • Veltassa® statistically prevented hyperkalemia with more patients being able to maintain Mineralocorticoid Receptor Antagonists (MRA) therapy at target doses compared to placebo
  • Patients with chronic kidney disease observed a greater benefit with Veltassa®
  • Veltassa® was generally well tolerated and without unexpected safety findings

“We are very encouraged by the full results of the DIAMOND trial which are a milestone for patients suffering from heart failure,” said Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. “Data from this trial demonstrated that Veltassa® controlled serum potassium and reduced the risk of recurrent hyperkalemia, while allowing more patients to be treated with guideline recommended, life-saving RAASi therapy.”

“These results are further evidence for the use of potassium binders to optimize heart failure medical therapy,” commented Prof. Javed Butler, Principal Investigator for the DIAMOND study. “RAASi offers significant survival benefits for these patients, but due to risk of hyperkalemia these therapies are unfortunately underutilized in practice. For cases where hyperkalemia is the dominant reason for not giving guideline-directed RAASi therapy, Veltassa® can be an enablement strategy to allow patients to get optimized RAASi therapy while simultaneously lowering the risk of hyperkalemia.”

To date, Veltassa is the only potassium binder studied in placebo-controlled trialsproven to control potassium without compromising RAASi in a variety of patient profiles.

Vifor Pharma continues to support several real world data generation programs with the ongoing phase-IV PLATINUM study and the CARE-HK in HF global registry to evaluate evidence-based care using Veltassa® in chronic kidney disease and heart failure patients. First results on the baseline data and retrospective analyses from CARE-HK in HF are expected in 2022.

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.

About the DIAMOND trial

This prospective phase-III multicenter, double-blind, randomized withdrawal, placebo-controlled trial was designed to evaluate the potential role of Veltassa® in enabling patients with, or at high risk of, hyperkalemia to remain on RAASi therapy. DIAMOND is the largest interventional study for potassium binders assessing control of serum potassium, hyperkalemia events, and enablement of RAASi in heart failure patients with reduced ejection fraction and hyperkalemia in more than 1,000 patients. On recommendation of the independent study Executive Committee and due to COVID-19 impact on recruitment, the primary endpoint has been changed in June 2021 to investigate the role of Veltassa® in controlling serum potassium, preventing hyperkalemia and maintain RAASi use in heart failure patients.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Contact and further information:

Nathalie Ponnier
Global Head Corporate Communications
+41 79 957 96 73
media@viforpharma.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(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

Data from Incyte’s Robust and Progressing Oncology Portfolio to be Presented at 2022 EHA Annual Meeting26.5.2022 12:00:00 CEST | Press release

Incyte (Nasdaq:INCY) today announced that multiple abstracts featuring data from its oncology portfolio will be presented at the upcoming European Hematology Association 2022 (EHA2022) Congress (June 9-17; virtual and in Vienna). “We are committed to advancing science that can lead to solutions for patients with serious unmet medical needs, including those with cancer,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “For that reason, we look forward to convening with the oncology community and presenting data from across our portfolio, including both Incyte-led and partnered programs.” Key abstracts accepted by EHA include: Oral Presentation Long-term Efficacy and Safety Results from an Ongoing Open-Label Phase 2 Study of Parsaclisib for the Treatment of Autoimmune Hemolytic Anemia (AIHA) (Abstract #S286. Session: Transfusion and Autoimmune Hemolytic Anemia. Session Time: Friday, June 10, 11:30 a.m. - 12:45 p.m.) Poster Presentations A Real-World Evaluation of the Association

500 Billion Gallons of Water Prevented from Flooding Communities in 2021, Using Xylem Technology26.5.2022 12:00:00 CEST | Press release

Solutions from global water technology company Xylem (NYSE:XYL), helped prevent more than 500 billion gallons of polluted water from flooding communities in 2021, according to its annual Sustainability Report. The report highlights the Company’s work with customers and partners to solve the world’s greatest water challenges. It also details Xylem’s progress to reduce its operational footprint, including cutting Scope 1 and 2 greenhouse gas (GHG) emission intensity by 12 percent and water use by 22 percent, versus 2019. “It’s a great privilege to have a leading portfolio of technologies and services to help our customers and communities solve the water challenges so central to a more sustainable world,” said Patrick Decker, president and CEO of Xylem. “We have a responsibility to make a difference, working alongside our customers and partners, and the communities we all serve. That’s why our sustainability report is more than a set of numbers. It’s a report card on the difference we’re

H.I.G. Capital Expands Its Capital Formation Middle East Team with the Addition of Oliver Slade26.5.2022 12:00:00 CEST | Press release

H.I.G. Capital, LLC ("H.I.G."), a leading global alternative investment firm with over $49 billion of capital under management, is pleased to announce that Oliver Slade has joined the firm’s Capital Formation Group, as a Managing Director, based in Dubai. Oliver will be responsible for capital raising and investor relations activities in the Middle East. He has been based in the region since 2008 and has over 17 years of experience in alternative assets. Oliver joins H.I.G. from Partners Group, where he was the Head of Middle East and Africa, responsible for the development and capital raising activities across private markets funds and solutions in the region. Prior to Partners Group, Oliver held a similar role at GAM investments. Jordan Peer Griffin, Executive Managing Director and Global Head of Capital Formation, commented: “We are delighted to welcome Oliver to H.I.G. Given his experiences in the region, Oliver is a key addition to establish a local presence in the Middle East, wh

SCREEN Increases Efforts to Reduce the Environmental Impact of the Semiconductor Industry26.5.2022 10:43:00 CEST | Press release

SCREEN Semiconductor Solutions Co., Ltd. (SCREEN SPE), a subsidiary of SCREEN Holdings Co., Ltd., has announced it will increase its efforts to reduce the company’s environmental overall impact. The SCREEN Group is committed to both achieving a sustainable global society and to improving its sustainable value (social value) and has formulated a medium-term management plan titled Sustainable Value 2023 targeting these goals. The plan identifies specific issues in each of the environmental, social, and governance (ESG) fields. Concerning the environment, SCREEN is working to provide products and services that actively contribute to the reduction of ecological burden. Its efforts include improving the environmental performance of its products, reducing the effects of its business activities on climate change, promoting effective utilization of water resources, increasing recycling of products and parts, and helping to preserve biodiversity. Concretely, SCREEN SPE seeks to reduce the impac

CARVYKTI ® (ciltacabtagene autoleucel) Granted Conditional Approval by the European Commission for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma26.5.2022 09:10:00 CEST | Press release

Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced that the European Commission (EC) has granted conditional marketing authorization of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel in December 2017. CARVYKTI® is a chimeric antigen receptor T-cell (CAR-T) therapy featuring two B-cell maturation antigen (BCMA)-targeting single domain antibodies.1 CAR-T therapy is specifically developed