Novartis AG (NVS: Quote) Friday said it has received approval from the European Commission for Exjade, an oral drug used to subside iron overload in patients undergoing chelation therapy for non-transfusion-dependent thalassemia, or NTDT, syndrome.
The approval is based on results from the placebo-controlled study of iron chelation in NTDT patients.
Thalassemia is a genetic disorder affecting red blood cell production, and thereby causing anemia. NTDT, unlike many other types of thalassemia, don't receive regular transfusion, subsequently resulting in a chronic iron overload.
Certain other health complication including liver fibrosis and cirrhosis, blood clots, bone disease, pulmonary hypertension, can also lead to higher iron concentration.
At least three quarters of a million people worldwide have NTDT syndromes, according to published studies.
In the pivotal study, named THALASSA, Exjade showed a significant dose-dependent decrease in concentration of iron-burden in the body as well as liver, compared to placebo. Meanwhile, the overall adverse event rate for Exjade was similar to the placebo arm.
by RTT Staff Writer
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