VIFOR-PHARMA
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 trials proven 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.
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