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ST. GALLEN, Switzerland – Regulatory news:
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Vifor Pharma today announced positive results in the final phase IIIb DIAMOND trial of Veltassa ® in patients with heart failure with overt hyperkalaemia or a history of hyperkalaemia while being treated with a renin-angiotensin aldosterone system inhibitor (RAASi). Veltassa ® demonstrated a statistically significant difference from placebo for the primary endpoint of serum potassium levels in a high-risk population.
85% of over 1000 patients at high risk of hyperkalaemia or active hyperkalaemia could be optimized for the recommended and life-saving RAASi therapy, including mineralocorticoid receptor antagonists, with Veltassa ® during the start-up phase of the study. This shows that the gap between guideline recommendations and real world practice regarding the use of RAASi can be bridged with Veltassa ® . Veltassa ® was generally well tolerated and without unexpected safety results. Vifor Pharma expects the main results of the trial to be presented at a major cardiology conference in the first half of 2022.
“We are delighted and very encouraged by the positive reading of the DIAMOND trial for the heart failure patient community,” said Dr Klaus Henning Jensen, Medical Director of Vifor Pharma. “RAASi therapy saves lives and delays disease progression, but unfortunately many patients with heart failure are undertreated due to the risk of hyperkalemia. Hyperkalemia is a serious illness with fatal consequences. These data support effective management of chronic hyperkalaemia in heart failure patients on optimal RAASi therapy with Veltassa ® . We look forward to presenting the detailed data to the scientific community in the first half of 2022. ”
“This trial makes a significant contribution to the growing body of evidence showing the importance of using Veltassa ® to enable RAASi and ensure optimal treatment in a high-risk population, ”commented Professor Javed Butler, Principal Investigator of the DIAMOND study. “The body of evidence from the trials with patiromer suggests the treatment to control serum potassium and prevent hyperkalaemia in patients with heart failure by aiding optimal longer-term medical treatment.”
Vifor Pharma continues to support multiple data generation programs with the ongoing PLATINUM Phase IV study and the global CARE-HK in HF registry to drive evidence-based care using Veltassa ® in patients with chronic renal failure and heart failure.
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About the DIAMOND trial
This global, multicenter, double-blind, placebo-controlled study was designed to assess the potential role of Veltassa ® allowing patients with hyperkalaemia or at high risk to remain on RAASi therapy. On the recommendation of the independent study’s executive committee and due to the impact of COVID-19 on recruitment, the primary endpoint was changed in June 2021 to study the role of Veltassa ® in the control of serum potassium, the prevention of hyperkalaemia, and the maintenance of RAASi use in patients with heart failure.
About the Vifor Pharma Group
The Vifor Pharma Group is a global pharmaceutical company. It aims to become the world leader in iron deficiency, nephrology and cardio-renal therapies. The company is a partner of choice for pharmaceuticals and innovative patient-centric solutions. The Vifor Pharma Group strives to help patients around the world with severe and chronic illnesses lead better and healthier lives. The company develops, manufactures and markets pharmaceutical products for precision patient care. The Vifor Pharma Group occupies a leading position in all of its main activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care). The Vifor Pharma group is headquartered in Switzerland and is listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).
For more information, please visit viveorpharma.com .
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