Novartis receives EU approval for Exjade

Novartis has announced that its new thalassaemia therapy Exjade has received approval from the European Commission.

The drug has been ratified for the treatment of chronic iron overload requiring chelation therapy in patients aged ten years and older with non-transfusion-dependent thalassaemia (NTDT) syndromes, when deferoxamine therapy is contraindicated or deemed inadequate.

It is the first oral therapy approved in Europe for this specification, with the positive regulatory decision based on results from the prospective placebo-controlled study Thalassa, which demonstrated the safety and efficacy of the drug.

At least three-quarters of a million people worldwide are affected by NTDT syndromes, which are often underdiagnosed and undertreated due to the fact that patients are not symptomatic at birth.

Herve Hoppenot, president at Novartis Oncology, said: "For the first time, Exjade will be available to thalassemia patients who are not regularly transfused but still suffer from the life-altering effects of excess iron."

This comes after the US Food and Drug Administration announced the approval of Novartis' Signifor therapy for Cushing's disease last week.