VIFOR-PHARMA
21.12.2021 07:02:12 CET | Business Wire | Press release
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
.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211220005646/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
Incyte Announces Positive CHMP Opinion for Opzelura® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis26.6.2026 13:30:00 CEST | Press release
If approved, Opzelura® (ruxolitinib) cream will be the first steroid-free, topical JAK treatment option in the European Union (EU) for adults with moderate atopic dermatitis (AD) for whom standard topical therapies have failedAD, the most common type of eczema which affects 230 million people globally,1 is a chronic, recurring, inflammatory and highly pruritic (itchy) skin condition that can have a significant impact on daily life2Phase 3 TRuE‑AD4 data supporting the positive CHMP opinion demonstrated that ruxolitinib cream met both co‑primary endpoints at Week 8, maintained disease control with as-needed treatment through Week 24 and was well tolerated3,4,5 Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids
Datroway® Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy26.6.2026 13:00:00 CEST | Press release
Recommendation based on TROPION-Breast02 phase 3 trial where Daiichi Sankyo and AstraZeneca’s Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival If approved, Datroway has potential to be the first TROP2 directed antibody drug conjugate for patients in EU with a demonstrated overall survival benefit as first-line treatment Datroway® (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use
DAYBU®(trofinetide) Recommended for Approval in the European Union by CHMP26.6.2026 12:49:00 CEST | Press release
-- European Commission decision expected in the coming months-- If approved, DAYBU®would become the first treatment for neurobehavioral symptoms of Rett syndrome in the European Union Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion following a re-examination procedure, recommending the granting of a marketing authorization for DAYBU® (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If granted marketing authorization by the European Commission, DAYBU® would be the first therapy approved for this indication in the European Union (EU). “The CHMP’s positive opinion for DAYBU® is an important milestone in our mission to bring this innovative therapy to the EU, where there are no therapies specifically approved for the neurobehavioral symptoms of this devastating
HTEC Showcases Lakebase Branching at Databricks’ Data & AI Summit26.6.2026 11:18:00 CEST | Press release
HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. The Solution was developed in collaboration with a leading risk and compliance technology provider who serves financial institutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260626875859/en/ HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. Solving Critical Development Bottlenecks in Regulated Environments At the core of the collaboration was a shared challenge: how to enable modern data workflows in an envi
Stallergenes Greer Named One of Switzerland’s Best Managed Companies for 202626.6.2026 10:28:00 CEST | Press release
Stallergenes Greer, a global leader in allergy care, has been recognised for its overall business performance, company culture, and sustained growth by receiving the prestigious 2026 Switzerland’s Best Managed Companies award. The 2026 Best Managed Companies programme award winners are among Switzerland’s best private companies. The awards are derived from Deloitte’s global Best Managed Companies awards programme, an internationally recognised programme that evaluates businesses based on their leadership in the areas of strategy, culture and commitment, capabilities, innovation, governance and financial performance. Applicants are evaluated by an independent jury of experts. The evaluation of the Switzerland awards is based on more than 30 years of observed practice from the global awards programme that has been rolled out in 50+ countries worldwide. This recognition reflects Stallergenes Greer's consistent ability to deliver on its strategic vision while maintaining the operational di
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