Ferinject® receives MHRA approval for a simplified dosing regimen for the treatment of iron deficiency

Mittwoch, 13. Juli 2011, ↓ direkt zum Download

Vifor Pharma announced today that Ferinject® (ferric carboxymaltose) has received approval for a new, simplified dosing regimen, which eliminates the need to calculate the iron dose with the complex Ganzoni formula.1,2 The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, the Mutual Recognition Procedure Reference Member State for Ferinject®, has approved a new version of its Summary of Product Characteristics (SmPC) reflecting this change. National approvals are expected to follow.

The new, simplified and convenient dosing regimen means Ferinject® can now be delivered in a standardised cumulative dose of 1000mg, 1500mg or 2000mg of iron, depending on the individual patient’s body weight and haemoglobin level. The recommended iron dose is shown in a simple table in the SmPC, aiding clinicians in administering the correct dose of iron to each patient. The new easy-to-use dosing regimen is expected to save clinicians time as determining the individual dose will be quicker.

In an additional change to the SmPC, the maximum amount of Ferinject® that can now be administered in a single intravenous (I.V.) injection has been increased from 200mg to 1000mg iron, excluding haemodialysis dependent chronic kidney disease.1 This gives clinicians greater flexibility and allows them to treat a larger patient population than before with a single dose of 1000mg.

The advantages of the simplified Ferinject® dosing regimen were compared with the standard treatment regimen of the most widely used I.V. iron compound, iron sucrose (Venofer®), in the FERGIcor study (see below). In this study, patients who received Ferinject® based on the convenient and simplified dosing regimen were iron replete in up to three infusions versus up to 11 infusions for Venofer®.3 Reducing the need for multiple applications may be more convenient in medical practice.3

Iron deficiency is common among patients with a number of medical conditions.4,5,6,7 Ferinject® has been shown to be a clinically effective I.V. iron treatment for patients with iron deficiency with inflammatory bowel disease, non-dialysis chronic kidney disease, chronic heart failure, and postpartum bleeding.3,8-13

About FERGIcor
FERGIcor (FERinject in GI disorders [IBD] to correct iron deficiency) was a large, phase III, multicentre,randomised, comparative study showing a significantly greater improvement in the correction of iron deficiency due to inflammatory bowel disease (IBD) with a simplified Ferinject® dosing regimen.3

About Ferinject®
Ferinject® is an innovative non-dextran intravenous iron (i.v.) 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 30 countries in Europe as well as in South Korea, Argentina, Russia, Australia and Lebanon, 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 illnesses. Vifor Pharma is evaluating new opportunities in the treatment of iron deficiency with Ferinject® in different therapeutic areas. Further trials with Ferinject® in chronic kidney disease (CKD), oncology (anaemia in cancer patients), cardiology (chronic heart failure), patient blood management and gynaecology are ongoing.

1. Ferinject® Summary of Product Characteristics
2. Venofer® Summary of Product Characteristics
3. Evstatiev R; Marteau P, Iqbal T et al.. Poster # 0420 at UEGW 2010, Barcelona.
4. Kulnigg S et al. Am J Gastroent 2008; 103: 1182-92.
5. McClellan W et al. Curr Med Res Opin 2004; 20:1501-10.
6. Silverberg DS et al. J Am Coll Cardiol. 2000; 35 (7):1737-44.
7. Bhandal N. et al. BJOG. 2006; 113: 1248-52.
8. Tagboto S. J Renal Care 2009; 35 (1): 18-22.
9. Anker SD et al. NEJM 2009: 361: 2436-48.
10. Van Wyck DB et al. Obstetrics & Gynecology 2007; 100: 267-8.
11. Seid MH et al. Am J Obstet Gynecol. 2008: 199: 435.
12. Van Wyck DB, et al. Transfusion. 2009 Dec; 49(12):2719-28.
13. Covic A, Mircescu G. Nephrol Dial Transplant. 2010 Aug; 25(8):2722-30.

Vifor Pharma, ein Unternehmen der Galenica Gruppe, ist eine der weltweit führenden Gesellschaften im Bereich Erforschung, Entwicklung, Herstellung und Vermarktung von pharmazeutischen Produkten zur Behandlung von Eisenmangel. Das Unternehmen bietet zudem ein diversifiziertes Portfolio an verschreibungspflichtigen Medikamenten und nicht verschreibungspflichtigen (OTC) Produkten an. Vifor Pharma mit Sitz in Zürich, Schweiz, baut seine globale Präsenz laufend aus und verfügt über ein umfassendes Netzwerk aus Tochtergesellschaften und Partnern weltweit.


Beatrix Benz

Head of Global Communications & Public Affairs

Vifor Pharma AG

Global Communications
Flughofstrasse 61
CH-8152 Glattbrugg

+41 58 851 80 00
+41 58 851 80 01

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