Novartis’ Exjade receives full European approval

Novartis has revealed that its treatment for transfusional iron overload, Exjade, has been approved by the European Commission for use in all 25 EU member states.

This means the drug will soon be launched in the UK, although NICE approval will determine whether or not Exjade will be available on the NHS.

Excess iron is a problem associated with patients who receive regular blood transfusions and it can lead to potentially life-threatening conditions, like thalassaemia, myelodysplastic syndromes and sickle cell disease.

Levels of iron can be reduced in these patients through the use of iron chelators like Exjade, which Novartis describes as the first oral iron chelator to be approved in the EU for patients with a range of underlying diseases.

Professor John B Porter of the department of haematology at University College London stated: “The approval of Exjade in the Europe Union as a new therapy for transfusional iron overload is most welcome. This allows for the first time an effective, once daily oral monotherapy for transfusional iron overload.”

“This is also the first oral treatment available for transfusional iron overload where the dose response effect on iron balance has been systematically studied on a scale not previously undertaken with iron chelation therapy,” he added.

Clinical trials for Exjade demonstrated that the drug was effective in reducing the iron burden in patients, particularly in patient with moderate to severe iron overload. If dosed appropriately, Exjade is as Desferal in reducing the iron burden.

Chelating agents can be used to treat other heavy metal build-ups in the body,

Exjade was approved by the FDA in November 2005.

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