ST. GALLEN, Switzerl--(뉴스와이어)--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.

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