EU Commission approves Exjade (Novartis) for treatment of Iron Overload with Thalassemia Syndromes

Novartis announced that the European Commission has approved Exjade (deferasirox) for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients aged 10 years and older with non-transfusion-dependent thalassemia (NTDT) syndromes. Exjade is the first oral treatment approved in the European Union (EU) specifically indicated for the treatment of chronic iron overload in patients with these types of thalassemia.

The approval is based on results from the first prospective placebo-controlled study of iron chelation in NTDT patients, THALASSA, which showed a significant dose-dependent decrease in iron burden compared to placebo (p<0.001)[1]. in this pivotal study exjade significantly reduced the concentration of iron in the liver known as liver iron concentration lic as well as the amount of iron anywhere in the body measured by serum ferritin. the overall adverse event rate for exjade was similar to the placebo arm.>