Phase-IIIb trial demonstrates statistically significant outcome on the primary endpoint
Largest study to date showing benefit of Veltassa® (patiromer) in high risk patient population with heart failure
Results suggest that treatment with Veltassa® is beneficial in heart failure patients to control serum potassium levels
Veltassa® enabled 85% of patients to be optimized to guideline-recommended doses of RAASi
Vifor Pharma to present full data at a major conference in H1 2022
ST. GALLEN, Switzerland--(BUSINESS WIRE)--Regulatory News:
AD HOC ANNOUNCEMENT PURSUANT TO ART. 53 LR
Vifor Pharma today announced positive findings in the completed phase-IIIb DIAMOND trial of Veltassa® in heart failure patients with either manifest hyperkalemia or with a history of hyperkalemia while treated with renin-angiotensin aldosterone system inhibitor (RAASi) therapy. Veltassa® demonstrated a statistically significant difference versus placebo for the primary endpoint to serum potassium levels in a high risk population.
85% of the more than 1,000 patients with either high risk of hyperkalemia or active hyperkalemia were able to be optimized to guideline recommended, life-saving RAASi treatment, including mineralocorticoid receptor antagonists, with Veltassa® during the run-in phase of the study. This shows that the gap between guideline recommendations and real-world practice regarding the use of RAASi can be addressed with Veltassa®. Veltassa® was generally well tolerated and without unexpected safety findings. Vifor Pharma expects the key trial results to be presented at a major cardiology conference in H1 2022.
“We are delighted and very encouraged about the positive read-out from the DIAMOND trial for the heart failure patient community,” said Dr. Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. “RAASi therapy saves lives and delays disease progression, but unfortunately many patients with heart failure are insufficiently treated due to risk of hyperkalemia. Hyperkalemia is a serious condition associated with life-threatening consequences. These data support an effective management of chronic hyperkalemia 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 to use Veltassa® to enable RAASi and ensures optimal treatment in a high-risk population”, commented Prof. Javed Butler, Principal Investigator for the DIAMOND study. “The totality of evidence from the trials with patiromer suggests the treatment to control serum potassium and preventing hyperkalemia in heart failure patients aiding longer term optimal medical therapy.”
Vifor Pharma continues to support several data generation programs with the ongoing phase-IV PLATINUM study and the CARE-HK in HF global registry to drive evidence-based care using Veltassa® in chronic kidney disease and heart failure patients.
About the DIAMOND trial
This global, multicenter, double-blind, placebo controlled 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. 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.
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.