Ferinject®: FAIR-HF study meets primary endpoints in patients with Iron Deficiency and Chronic Heart Failure

(PresseBox) ( Bern, )
Vifor Pharma has reached an important milestone in its clinical development program: The FAIR-HF Study - a study assessing Ferinject® (ferric carboxymaltose) in patients with iron deficiency (with and without anaemia) and chronic heart failure - was recently completed and has met the primary endpoints. The detailed results will be presented at the American Heart Association Meeting in Orlando Florida (USA) on 17 November 2009. Ongoing development of scientific evidence supporting the use of Ferinject® outside of dialysis is a key element within Vifor Pharma's strategy. The current study results represent an important step by implementing this strategy.

FAIR-HF (Ferinject® Assessment in patients with IRon deficiency and chronic Heart Failure) is a large, multi-centre, randomised, double-blind, placebo-controlled, phase III study of patients with chronic heart failure (CHF) and iron deficiency (with or without anaemia). The study met both of the two primary endpoints compared with placebo treatment. FAIR-HF was designed to test whether correction of Iron Deficiency (ID) using intravenous iron (ferric carboxymaltose, the active ingredient of Ferinject®) confers a benefit in symptomatic CHF patients with and without anaemia. The two primary endpoints were the self-reported Patient Global Assessment (PGA) at Week 24, and the New York Heart Association (NYHA) class at Week 24, adjusted for baseline NYHA class.

A detailed analysis of the results will be presented at the American Heart Association (AHA) meeting in a late breaking clinical trial session (Orlando, USA) on 17 November 2009.

Trial Design

FAIR-HF (Clinical Trials.gov NCT00520780) is a multi-centre, randomised, double-blind, placebocontrolled study recruiting ambulatory, symptomatic CHF patients with Left Ventricular Ejection Fraction (LVEF) ?40% (NYHA II) or ?45% (NYHA III), ID (ferritin <100 ng/mL, or ferritin 100-300 ng/mL with a transferrin saturation [TSAT] <20%), and haemoglobin 9.5-13.5 g/dL. Patients were randomised in a 2:1 ratio to receive ferric carboxymaltose (Ferinject®) 200 mg iron i.v. or saline i.v. weekly until iron repletion (correction phase), then monthly until Week 24 (maintenance phase). Primary endpoints were self-reported Patient Global Assessment at Week 24, and NYHA class at Week 24, adjusted for baseline NYHA class.

About Chronic Heart Failure

Chronic Heart Failure (CHF) is a common and serious medical condition, which is recognised as a major and escalating public health problem that engenders considerable costs both in economic and personal terms. In developed countries, total expenditure on CHF ranges between 1 and 2% of the total healthcare budget. The major symptoms of heart failure, i.e. shortness of breath and exhaustion, are a consequence of altered function and/or structure of the heart and the associated body response. Approximately 0.4% to 2% of people in the industrialised world suffer from CHF; CHF accounts for 20% of hospitalisations. Iron deficiency (ID) and anaemia are common in patients with CHF. Presence of anaemia is associated with increased morbidity and mortality in CHF, and ID is a major reason for development of anaemia.

About Ferinject®

Ferinject® is an innovative intravenous iron replacement product from the research & development pipeline of Vifor Pharma. Ferric carboxymaltose, the active pharmaceutical ingredient of Ferinject®, overcomes the unmet clinical needs of i.v. iron therapy as Ferinject® is not associated with dextraninduced hypersensitivity reactions and has a low potential for iron toxicity. High doses of Ferinject® can be rapidly administered in a variety of indications.

So far, Ferinject® gained marketing authorisation in 18 European countries and Switzerland for the treatment of iron deficiency where oral iron is ineffective or can not be used. In many countries, intravenous iron replacement products are primarily used to treat dialysis patients. However, iron deficiency is also part of many other illnesses representing a great market potential for Vifor Pharma's iron product. Ongoing development of scientific evidence supporting the use of Ferinject® outside of dialysis therefore take top priority. Vifor Pharma will evaluate new opportunities in the treatment of iron deficiency with Ferinject® in different therapeutic areas. Trials with Ferinject® in CKD (Chronic Kidney Disease), Oncology (anaemia in cancer patients), Gastroenterology (inflammatory bowel diseases), Surgery (pre-operative anaemia), and Gynaecology are implemented or planned.
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