EMA approves label extension for Novartis’ Exjade
This article was originally published in Scrip
The European Medicines Agency has approved a label extension for Novartis' iron overload treatment Exjade (deferasirox), making the drug available to patients with non-transfusion-dependent thalassemia syndromes aged 10 years and older.
This is in addition to Exjade’s various previous indications to treat patients with chronic iron overload due to blood transfusions.
The label extension is in line with the recommendation made by the CHMP in November 2012. The approval is based on data from the THALASSA trial, which showed a significant dose-dependent decrease in iron burden compared to placebo (p<0.001).>
Hervé Hoppenot, president of 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."