VIFOR-PHARMA
24.9.2020 07:02:06 CEST | Business Wire | Press release
Regulatory News:
Vifor Pharma today announced topline data from its AFFIRM-AHF study evaluating the effect of Ferinject® (intravenous ferric carboxymaltose) on heart failure hospitalizations and cardiovascular mortality in iron-deficient patients hospitalized for acute heart failure (AHF), compared to placebo. The trial narrowly missed statistical significance on its composite primary endpoint of reducing the risk of total heart failure hospitalizations and cardiovascular death. A pre-specified sensitivity analysis considering the impact of the COVID-19 pandemic, revealed a statistically significant difference in favor of Ferinject® on cardiovascular mortality and hospitalization for heart failure. The study results will be presented at the American Heart Association (AHA) congress in November this year.
“This trial makes a significant contribution to the growing body of evidence showing the importance of detecting and managing iron deficiency in heart failure”, said Prof Piotr Ponikowski, Principle Investigator and Head of the Department of Heart Diseases, Wroclaw Medical University and Head of the Center for Heart Diseases at the University Hospital, Wroclaw, Poland. “The totality of evidence from the trial suggests that treatment with intravenous ferric carboxymaltose of patients’ hospitalized due to AHF with concomitant iron deficiency is clinically beneficial. We look forward to presenting the detailed data to the scientific community.”
“We are delighted with the completion of the AFFIRM-AHF trial and are very encouraged by the results,” said Dr Klaus Henning Jensen, Chief Medical Officer Vifor Pharma. “Iron deficiency is a frequent, yet often unrecognized, co-morbidity in heart failure, present in approximately 50% of patients. Ferinject® is the only iron therapy included in the ESC guidelines to improve clinical symptoms and quality of life in heart failure patients with iron deficiency.”
AFFIRM-AHF is the first of three ongoing mortality and morbidity trials including FAIR-HF2 and HEART-FID to understand the full potential of Ferinject® in prolonging and improving quality of life of those suffering from heart failure and iron deficiency. AFFIRM-AHF was a randomized, double-blind placebo-controlled trial with 1,132 patients who had heart failure with reduced and mid-range ejection fraction (LVEF<50%) and iron deficiency (serum ferritin <100ng/mL or serum ferritin 100-299 ng/mL with TSAT <20%). Patients were randomized to receive either Ferinject® or placebo before being discharged from the hospital following an episode of AHF and followed for 52 weeks. Ferinject® was generally well tolerated and without unexpected safety findings.
Hospitalization due to AHF is the leading cause for hospital admissions in patients above 65 years old. Post-discharge outcomes are still poor with readmission rates exceeding 30% during the first 6 months post discharge and 1-year mortality above 20%. Iron deficiency is present in the majority of these patients and unfavorably impacts the outcomes.
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 the 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; Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care); and OM Pharma. 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 www.viforpharma.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20200923005818/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
FDA Issues Modified Risk Tobacco Product Orders for 20 ZYN Nicotine Pouch Products30.6.2026 18:19:00 CEST | Press release
FDA’s decision makes ZYN the first nicotine pouch product to receive MRTP orders authorizing reduced-risk claims versus cigarettes Philip Morris International Inc. (PMI) (NYSE: PM) today announced that the U.S. Food and Drug Administration (FDA) issued Modified Risk Tobacco Product (MRTP) orders for 20 variants of ZYN nicotine pouch products. These are the first MRTP orders granted for nicotine pouches, allowing PMI U.S. to market the following claim for the authorized ZYN products: “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” “FDA’s decision is an important moment for the more than 45 million legal-age nicotine consumers in America,” saidStacey Kennedy, PMI U.S. CEO. “Today’s news ensures these adultshave access to accurate, science-based information, including FDA-authorized evidence that switching from cigarettes to ZYN reduces the risk of smoking-related diseases like heart disease
Caidya Announces Strategic Combination with Simbec-Orion Bridging Early Scientific Insight and Global Clinical Execution30.6.2026 17:00:00 CEST | Press release
Caidya today announced a strategic combination with Simbec-Orion designed to close the divide between early scientific insight and global clinical execution. The combination of Caidya and Simbec-Orion creates a differentiated specialty clinical CRO platform that enables programs to scale, maintaining focus, speed, and accountability. The strategic combination brings together complementary strengths to create a more complete development partner for innovative biopharma companies. With established operations across Europe, the Americas, APAC, and China, the combined organization provides meaningful expertise and execution capabilities in the regions that matter most. Simbec-Orion brings early-phase clinical pharmacology capabilities alongside deep therapeutic expertise for later stage complex oncology and rare disease trials, helping sponsors shape critical decisions early in the development lifecycle. Together, the organizations strengthen their ability to support complex, cross-border
Archer® Proves Purpose-Built AI Beats General-Purpose LLMs on Regulatory Change Management: 95% Verified Accuracy, 80x Faster, 92% Lower Cost30.6.2026 16:13:00 CEST | Press release
In a head-to-head benchmark, a leading general-purpose LLM was confidently wrong 35% of the time on regulatory dates. Archer Evolv™ shipped zero errors. For enterprises deploying AI in compliance, a wrong date is a missed deadline. The more dangerous failure is a wrong answer the model returns with high confidence, one that flows silently into a compliance calendar and is only discovered after the window has passed. Archer® today released results showing purpose-built AI beats a general-purpose large language model (LLM) on regulatory work, and it’s not close. This head-to-head test compared Archer’s purpose-built, vertical-specific AI and proprietary data sets against a leading general-purpose LLM, on a core compliance task: determining the publication, effective and comment-close dates of regulatory documents across six jurisdictions. General-purpose models are a genuine breakthrough, and this is no referendum on their quality. The question Archer set out to answer is narrower and mo
Altasciences Supports Key Development Milestone for Steel Therapeutics’ Lead Therapeutic Candidate, Fizurex™30.6.2026 16:08:00 CEST | Press release
Altasciences, a leading drug development organization, today announced a significant milestone in the development of Steel Therapeutics, Inc.’s pivotal toxicology study for its lead product candidate, Fizurex™, for the treatment of anal fissures. The successful completion of the study plays a significant role in the advancement of Fizurex™ toward first-in-human trials. The GLP-compliant study demonstrated a favorable safety profile, which has advanced Steel Therapeutics' plans to submit an Investigational New Drug (IND) application for Fizurex™ to the FDA in Q3 2026. Fizurex™, a patent-pending, single-use topical wipe, was designed to provide a standardized, accessible treatment option for a painful and often undertreated medical condition. The product builds on years of use through compounding pharmacy prescriptions and is now advancing toward clinical development and regulatory review. "We are proud to have supported Steel Therapeutics with the generation of the high-quality safety d
Interactive Brokers Expands Access to Korean Equities with Launch of Nextrade ATS30.6.2026 16:00:00 CEST | Press release
IB SmartRouting℠ Routes Orders to the Best Available Price Between KRX and Nextrade Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced the launch of select Korean equities through Nextrade, South Korea's first Alternative Trading System (ATS). The addition of Nextrade builds on Interactive Brokers' earlier launch of the Korea Exchange (KRX), through which it became the first major US-based broker to provide global investors with direct access to Korean equities. Clients trading on Nextrade benefit from significantly extended trading hours and access to additional liquidity. Interactive Brokers has enabled IB SmartRouting℠ across both the Korea Exchange (KRX) and Nextrade, automatically routing orders to the venue offering the best price. This helps clients achieve best execution while providing greater flexibility and more opportunities to participate in one of Asia's most dynamic equity markets. Korea's equity market ranks among the top global exchanges by
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