Communiqué de presse

SMC approves Ferinject® (ferric carboxymaltose) for the treatment of iron deficiency anaemia

Lundi 13 juin 2011, ↓ accès direct au téléchargement

Bagshot, UK – The Scottish Medicines Consortium (SMC) has today recommended the use of Vifor Pharma’s Ferinject® (ferric carboxymaltose), the intravenous (I.V.) iron for the treatment of iron deficiency anaemia (IDA) when oral iron preparations are ineffective or cannot be used.

This provides an immediate opportunity for patients in Scotland to benefit from rapid correction of their anaemia especially in Chronic Kidney Disease, Chronic Heart Failure and Inflammatory Bowel Disease.

Ferinject® has a proven efficacy and safety profile that has been demonstrated through several large clinical trials confirming that up to 1000 mg of Ferinject® can be administered without a test dose in 15 minutes. This offers a significant advance for patients and healthcare professionals over Venofer® (iron sucrose), which requires five separate hospital visits to administer the same dose of 1000 mg of Iron.

The cost implications associated with this reduced requirement for hospital visits with Ferinject® was an important consideration for the SMC, with Ferinject® showing that if all patients currently receiving iron sucrose or iron dextran were to receive Ferinject®, NHS Scotland would actually save money.1

Neil Turner, Professor of Nephrology at the University of Edinburgh and Chairman of Kidney Research UK, stated “Reduction of hospital visits to once, instead of up to five times to receive intravenous iron is likely to be welcomed both by patients, and NHS organisations which are striving to operate ever more effectively and efficiently in these financially difficult times.”

Dr. Senthil Vel, Medical Director at Vifor Pharma UK Ltd, says “We are delighted with this positive decision by the Scottish Medicines Consortium, which is based on a submission of data from 14 clinical studies involving more than 3,400 patients. Our continued aim is to make Ferinject more accessible to those patients who require rapid intravenous iron, thus providing them with a more flexible and patient-friendly treatment regimen, with the ultimate aim of improving their quality of life.”


NOTES TO EDITORS 

About IDA
IDA is defined as a state in which iron stores are inadequate for normal blood formation, and the requirements exceed the supply. Iron deficiency anaemia results from low or depleted stores of iron. In severe cases red cells in a patient with IDA are both microcytic (small) and hypochromic (pale),2 and values for mean corpuscular volume (MCV) and mean corpuscular Hb concentration (MCHC) are characteristically changed.

According to the World Health Organization (WHO) it is estimated that about 700 million people have iron deficiency anaemia (IDA).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.

For full Ferinject® Specific Product Characteristics, please visit http://www.medicines.org.uk


References
1. Ferric carboxymaltose 50mg iron/mL solution for injection/infusion (Ferinject®) SMC No. (463/08)
2. Danielson BG et al. Iron Therapy with Special Emphasis on Intravenous Administration. Switzerland: Vifor (International) Inc. Publisher 1st Edition, 1996.
3. World Health Organisation. Preventing and controlling Iron Deficiency Anaemia through primary health care. Available at: http://www.who.int. Accessed: September 2010.

Vifor Pharma, une entreprise du Groupe Galenica, est l’un des leaders mondiaux en matière de découverte, développement, fabrication et commercialisation de produits pharmaceutiques utilisés dans le traitement de la carence en fer. La société propose également un portefeuille diversifié de produits de prescription et de produits délivrés sans ordonnance (OTC). Vifor Pharma, dont le siège est à Zurich (Suisse), étend sans cesse sa présence mondiale et dispose d’un vaste réseau de filiales et de partenaires dans le monde.

Contact

Beatrix Benz

Head of Global Communications & Public Affairs


Vifor Pharma SA

Global Communications
Flughofstrasse 61
casa postale
CH-8152 Glattbrugg

Tél.:
+41 58 851 80 00
Fax:
+41 58 851 80 01

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