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.
Click here to receive FREE breaking news email alerts for Novartis AG and others in your portfolio
by RTT Staff Writer
For comments and feedback: firstname.lastname@example.org