VIFOR-PHARMA
31.8.2021 07:02:05 CEST | Business Wire | Press release
Regulatory News:
Vifor Pharma is pleased to announce that the European Society of Cardiology (ESC) included new recommendations and proposals in the 2021 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure for two of their key products, Ferinject® and Veltassa® .
With regard to iron deficiency, the following new recommendations for HF patients with reduced function of the heart are added:
- Periodic screening for iron deficiency is recommended in all HF patients (Class I).
- Ferinject® should be considered to reduce the risk of HF hospitalizations in symptomatic HF patients with iron deficiency (Class IIa).
- Ferinject® should be considered before and early after discharge in patients who have been hospitalized with acute heart failure and with iron deficiency to improve HF symptoms and reduce risk of re-hospitalizations (Class IIa).
The existing recommendation to consider Ferinject® in patients with HF and iron deficiency to alleviate HF symptoms, improve exercise capacity and quality of life remains unchanged (Class IIa designation). The results of the AFFIRM-AHF study are reflected in the update of the ESC guidelines. Ferinject® remains the only intravenous (i.v.) iron therapy specifically mentioned in the new ESC HF guidelines.
The guidelines also propose that the use of potassium binder agents like Veltassa® may allow RAAS inhibitor initiation or uptitration in a larger proportion of heart failure patients. In patients with chronic or recurrent hyperkalemia on RAAS inhibitor therapy Veltassa® may as well be initiated to maintain the patients on guidelines recommended doses of RAAS inhibitors. The new proposals further describe the unique evidence for RAASi enabling generated by Veltassa® through the clinical trials.
“We are very pleased with the new recommendations to the ESC’s guidelines in heart failure and are grateful for this development for the patients,” commented Klaus Henning Jensen, Chief Medical Officer of Vifor Pharma. “With improved diagnosis rates of iron deficiency and enabling RAASi, more patients can benefit from treatment. Reducing the risk of heart failure hospitalizations and improving symptoms are key therapeutic goals in the treatment of heart failure. We are particularly pleased by the consideration of Ferinject® and Veltassa® in the new treatment guidelines to achieve these therapeutic goals and believe this will enable us to further expand our role in helping heart failure patients with iron deficiency and hyperkalemia live better, healthier lives.”
The ESC HF guidelines aim to provide practical, evidence-based recommendations for the diagnosis and treatment of HF, thereby improving and harmonizing standards of diagnosis and treatment of cardiovascular diseases for physicians, and potentially optimizing patient care. The ESC HF guidelines are updated periodically, with the 2021 version published at the virtual ESC congress end of August 2021.
The 2021 ESC guidelines are published under: www.escardio.org/Guidelines
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 .
About AFFIRM-AHF
The AFFIRM-AHF study was a multi-center, randomized, double-blind, placebo-controlled trial, comparing the effect of intravenous ferric carboxymaltose (FCM) on hospitalizations and mortality in iron deficient patients admitted for acute heart failure. The study demonstrated that administration of Ferinject®
reduced the risk of HF hospitalizations and improved quality of life with no apparent effect on the risk of cardiovascular death.
About Ferinject®
Ferinject®
/Injectafer®
(ferric carboxymaltose) is a leading i.v. iron therapy with market authorization in 84 countries by the end of June 2021. More than 16 million patient years of experience have helped to establish Ferinject®
/ Injectafer®
as a trusted brand, with clinical benefits demonstrated by its efficacy and safety data2
.
About Veltassa®
Veltassa®
(patiromer) is a potassium binder approved for the treatment of hyperkalemia. Veltassa®
was specially designed to exchange calcium rather than sodium for potassium ions, ensuring suitability for patients who cannot tolerate even small increases in sodium. Veltassa®
should not replace emergency treatment for life-threatening hyperkalemia.
References:
1
Anker, S.,D. (2018). Effects of ferric carboxymaltose on hospitalisations and mortality rates in iron-deficient heart failure patients: an individual patient meta-analysis. Eur J Heart fail. 20(1):125-133. doi: 1002/ejhf.823.
2
Scott Drugs. 2018 Mar;78(4):479–493. doi: 10.1007/ s40265-018-0885-7.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210830005519/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
EVE Energy Showcases All-Scenario Energy Storage Solutions at The Smarter E Europe 20261.7.2026 03:45:00 CEST | Press release
EVE Energy unveiled its Mr. Big Family series, a 6.9+ MWh energy storage system, and all-scenario energy storage solutions at Intersolar Europe in Munich. Drawing on traceable large-cell technology, proven large-scale energy storage project delivery experience, and global delivery capabilities, the company is addressing Europe's diverse energy storage requirements across utility-scale, commercial & industrial (C&I ), and data center segments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260630889717/en/ EVE Energy showcases its Mr. Giant 3.0 6.9+ MWh energy storage system at The Smarter E Europe 2026 in Munich, Germany Advancing Large-Cell Technology with Global Project Validation As one of the first companies to focus on large-capacity energy storage cells, EVE Energy has iteratively upgraded its cell platform from 560 Ah and 628 Ah to 702 Ah, adhering to a stacking process route throughout. At the exhibition, the Mr. Gia
Bending Spoons S.p.A. announces pricing of initial public offering1.7.2026 01:56:00 CEST | Press release
Bending Spoons S.p.A. (“Bending Spoons”), a leading technology company, today announces the pricing of its initial public offering (“IPO”) at $29.00 per share. A total of 57,971,015 ordinary shares are being offered, of which 34,398,640 shares are being offered by Bending Spoons and 23,572,375 shares are being offered by certain selling shareholders (the “Selling Shareholders”). Bending Spoons will not receive any proceeds from any sale of shares by the Selling Shareholders. The shares are expected to begin trading on the Nasdaq Global Select Market under the ticker symbol “BSP” on July 1, 2026. The offering is expected to close on July 2, 2026, subject to customary closing conditions. In addition, Bending Spoons and the Selling Shareholders granted the underwriters an option to purchase up to an additional 5,244,026 ordinary shares from Bending Spoons and up to an additional 3,451,626 ordinary shares from the Selling Shareholders at the initial public offering price, less underwriting
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
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
