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Novartis AG Announces FDA Approval For Exjade In Patients With Genetic Blood Disorder-Reuters


Wednesday, 23 Jan 2013 03:30pm EST 

Reuters reported that U.S. regulators said on January 23, 2013 they have approved Novartis AG's drug Exjade to remove excess iron in patients over the age of 10 who have a genetic blood disorder known as non-transfusion-dependent thalassemia, or NTDT. The new approval allows Novartis to also market the drug for NTDT. Patients with thalassemia have an abnormal form of hemoglobin, the protein in red blood cells that carries oxygen. The malfunction leads to the presence in the body of fewer red blood cells than normal. As a result patients may develop severe anemia and need regular blood transfusions. NTDT is a milder form of thalassemia that does not require frequent transfusions. Patients with the condition are nonetheless at risk of iron overload, which can lead to damage of various organs and potentially premature death. The new approval was given under the FDA's accelerated approval program, which gives patients earlier access to promising new treatments intended to treat serious or life-threatening illnesses while the Company conducts additional studies to confirm its clinical benefit. Exjade was approved based on clinical data showing it can reduce liver iron concentrations, which the FDA judged reasonably likely to predict a clinical benefit to patients. 

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