Novartis' Exjade approved in the UK

1 October 2006

Switzerland-based drug major Novartis says that Exjade (deferasirox) has been approved in the UK for the treatment of transfusional iron overload in patients who suffer from diseases such as thalassemia, sickle cell disease, myelodysplastic syndromes and other rare anemias.

The easy-to-administer, oral, once-daily iron chelator was developed to address the needs of patients who have been using the firm's Desferal (deferoxamine), which is administered via a 12-hour infusion. While it is the gold standard treatment, many patients stop or avoid therapy as it is painful and inconvenient, thus risking complications from the life-threatening cumulative toxicity which results from the transfusions used to treat chronic blood disorders.

The agent is cleared in the European Union for the treatment of chronic iron overload due to frequent blood transfusions in patients aged six and older with beta thalassemia major. Exjade's regulatory filings include data from a Phase III head-to-head trial with Desferal showing that treatment with the two agents on similar doses yielded similar reductions in liver iron concentration after one year.

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