Novartis oral iron chelator wins EU approval

The European Commission (EC) has granted approval for Exjade (deferasirox) as a new treatment to help patients with transfusional iron overload in all 25 member states of the European Union (EU).

Exjade is the only oral iron chelator to provide continuous chelation coverage to remove excess total body iron with a single daily dose. It means adults and children receiving regular blood transfusions now have a more convenient alternative to burdensome standard therapy through a once-daily drink.

Iron chelation is needed to help patients with thalassemia, sickle cell disease, myelodysplastic syndromes and other anemias who regularly receive transfusions. The current standard of care is a cumbersome infusion via pump that often lasts 8-12 hrs and must often be done daily.

"The approval of Exjade in the EU 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," said professor John Porter, at the Department of Haematology, University College London. "This is also the first oral treatment available for transfusional iron overload where the dose response effect on iron bal-ance has been systematically studied on a scale not previously undertaken with iron chelation therapy".