Novartis announced that the FDA has approved Exjade (deferasirox tablets for oral suspension) for the treatment of chronic iron overlaod in patients >10 years old with non-transfusion-dependent thalassemia (NTDT) and with a liver iron concentration of >5mg iron per gram dry weight and a serum ferritin measurement >300mcg/L.

The FDA approval is based on results from THALASSA, the first prospective placebo-controlled study of iron chelation in NTDT patients. Results showed a significant dose-dependent decrease in iron burden compared to placebo (P<0.001). Exjade significantly reduced liver iron concentration (LIC), as well as the amount of iron anywhere in the body, as measured by serum ferritin.

Since 2005, Exjade has been approved for the treatment of chronic iron overload due to blood transfusions in adult and pediatric patients (aged >2 years). Exjade is available as 125mg, 250mg, and 500mg tablets for oral suspension in 30-count bottles.

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