EFFECT-HF demonstrates a significantly beneficial effect of Ferinject® on exercise capacity among patients with CHF and iron deficiency – confirms findings of previous studies

• The EFFECT-HF study evaluated the impact of intravenous Ferinject^® (ferric carboxymaltose) therapy versus standard of care on exercise capacity in symptomatic patients with chronic heart failure and iron deficiency
  
• The study met its primary endpoint demonstrating a statistically significant difference in peak oxygen uptake (VO₂) between treatment groups after 24 weeks, irrespective of anaemia status
  
• These results confirm and extend upon the findings of previous clinical studies showing that treatment with Ferinject^® has a beneficial effect on exercise capacity and symptoms in patients with heart failure and iron deficiency

EFFECT-HF was a multicentre, randomised, controlled, open-label study conducted in symptomatic patients with stable heart failure and iron deficiency¹. A total of 174 patients from nine countries were randomized to receive either Ferinject^® or standard of care for 24 weeks.

The study achieved its primary endpoint, demonstrating a statistically significant benefit with Ferinject^® versus standard of care for the change in peak VO₂ after 24 weeks of treatment. Analysis of secondary efficacy outcomes also found that Ferinject^® was associated with significant improvements in New York Heart Association (NYHA) functional class and self-reported Patient Global Assessment (PGA) compared with standard of care.

The results of the EFFECT-HF study were presented at the American Heart Association’s Scientific Sessions 2016 in New Orleans in November. Principal investigator, Professor Dirk van Veldhuisen, University of Groningen, The Netherlands, who presented the findings stated: “Iron deficiency is present in approximately 50% of patients with chronic heart failure², and has been associated with impaired exercise capacity³, poor quality of life⁴ and increased mortality². The EFFECT-HF study clearly demonstrates that treatment with ferric carboxymaltose provided a significantly beneficial effect on peak VO₂ compared with the control group. These results are in contrast to the findings in the IRONOUT⁵ study, also presented in the same session at AHA, which showed no effect of oral iron treatment on peak VO₂.”

The EFFECT-HF study results confirm and extend upon the findings of the FAIR-HF⁶ and CONFIRM-HF⁷ studies, which also demonstrated that treatment with Ferinject^® was associated with improvements in functional capacity and symptoms, in patients with chronic heart failure and iron deficiency. Building upon this body of evidence, AFFIRM-HF, a new study designed to compare the efficacy and safety of iron therapy with Ferinject^® (ferric carboxymaltose) against placebo in patients with acute heart failure and iron deficiency, will begin enrolment shortly.

Overall, the data from EFFECT-HF further reinforce the position of Ferinject^® as an effective treatment option for the correction of iron deficiency in chronic heart failure. The 2016 European Society of Cardiology (ESC) Guidelines for the diagnosis and treatment of acute and chronic heart failure, which were released in May this year, recommend that Ferinject^® should be considered for the treatment of all symptomatic patients with systolic heart failure and iron deficiency in order to alleviate heart failure symptoms, improve exercise capacity and quality of life⁸. These recommendations were based on the findings of the FAIR-HF⁶ and CONFIRM-HF⁷ studies.

For further information, please contact:

Media Relations:
Beatrix Benz, Head of Global Communications & Public Affairs
Tel.: +41 58 851 80 16
E-mail: media@viforpharma.com

About EFFECT-HF
The EFFECT-HF study was designed to evaluate the impact of Ferinject^® (ferric carboxymaltose) in comparison with standard of care, on exercise capacity in symptomatic patients with chronic heart failure and iron deficiency¹. Patients were randomised 1:1 to receive Ferinject^® or standard of care for 24 weeks. Over 24 weeks of treatment, Ferinject^® was found to have a significantly beneficial effect on exercise capacity, as assessed by change in peak oxygen uptake (VO₂), compared with standard of care. Ferinject^® was also found to significantly improve New York Heart Association functional class and patient global assessment.

About FAIR-HF and CONFIRM-HF
The FAIR-HF study was designed to evaluate the use of Ferinject^® in patients with chronic heart failure and iron deficiency⁶. Over 6 months of treatment, Ferinject^® was found to significantly improve patient global assessment, New York Heart Association functional class, 6-minute walk test distance and health-related quality of life, which, together, demonstrate the benefit of Ferinject^® in chronic heart failure patients with iron deficiency.

The CONFIRM-HF study evaluated the longer-term efficacy and safety of Ferinject^® in iron-deficient patients with chronic heart failure⁷. In this 12-month study, treatment of symptomatic, iron-deficient chronic heart failure patients with Ferinject^® resulted in sustainable improvement in functional capacity, symptoms and quality of life, and were also found to be associated with a risk reduction of hospitalisation for worsening chronic heart failure.

Vifor Pharma, a company of the Galenica Group, is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. The company also offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Vifor Pharma, headquartered in Zurich, Switzerland, has an increasingly global presence and a broad network of affiliates and partners around the world.

For more information about Vifor Pharma and its parent company Galenica, please visit www.viforpharma.com and www.galenica.com.

Ferinject^® (US brand name: Injectafer^®) is an innovative non-dextran-based intravenous (i.v.) iron replacement therapy discovered and developed by Vifor Pharma, a company of the Galenica Group. Ferric carboxymaltose is the active pharmaceutical ingredient of Ferinject^®. To date, Ferinject^® has gained marketing authorisation in more than 70 countries worldwide for the treatment of iron deficiency where oral iron is ineffective or cannot be used. In many countries, intravenous iron replacement products are primarily used to treat dialysis patients. However, iron deficiency is also a complication of many other diseases. Vifor Pharma is evaluating new opportunities in the treatment of iron deficiency with Ferinject^® in different therapeutic areas. Further clinical trials with Ferinject^® in chronic kidney disease (CKD), oncology (anaemia in cancer patients), cardiology (chronic heart failure), patient blood management and women’s health are ongoing.

References

1. Van Veldhuisen DJ, Ponikowski P, Metra M, et al. Effect of ferric carboxymaltose on exercise capacity in patients with iron deficiency and chronic heart failure (EFFECT-HF): A randomized controlled study. American Heart Association 2016 Scientific Sessions; November 16, 2016; New Orleans.
2. Klip IT, Comin-Colet J, Voors AA, Ponikowski P, et al. Iron deficiency in chronic heart failure: an international pooled analysis. Am Heart J 2013;165:575-582.
3. Jankowska EA, Rozentryt P, Witkowska A, et al. Iron deficiency predicts impaired exercise capacity in patients with systolic chronic heart failure. J Cardiac Fail 2011;17:899-906.
4. Enjuanes C, Klip IT, Bruguera J, et al. Iron deficiency and health-related quality of life in chronic heart failure: results from a multicenter European study. Int J Cardiol 2014;174:268-275.
5. Lewis GD, McNulty S, Hernandez AF, et al. Oral iron repletion effects on oxygen uptake in heart failure (IRONOUT HF). American Heart Association 2016 Scientific Sessions; November 16, 2016; New Orleans.
6. Anker SD, Comin-Colet J, Filippatos G, et al. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med 2009; 361:2436-2448.
7. Ponikowski P, van Veldhuisen DJ, Comin-Colet J, et al. Beneficial effects of long term intravenous iron therapy with ferric carboxymaltose in patients with symptomatic heart failure and iron deficiency. Eur Heart J 2015;36:657-668.
8. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur J Heart Fail. 2016;18:891-975.

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