The U.S. Food and Drug Administration (FDA) on Wednesday expanded the approved use of Exjade to treat patients ages 10 years and older who have chronic iron overload resulting from a genetic blood disorder called non- transfusion-dependent thalassemia (NTDT).

NTDT is a milder form of thalassemia that does not require individuals to get frequent red blood cell transfusions. However, over time, some patients with NTDT are still at risk for iron overload that can lead to damage to vital organs.

"Using our accelerated approval process, FDA is able to expedite the availability of this drug to patients who need to reduce excess iron," said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "Exjade is the first drug approved to treat patients with NTDT who show iron overload."

Exjade is marketed by East Hanover, New Jersey-based Novartis.

An estimated 1,000 people in the United States have thalassemia, according to the National Heart, Lung, and Blood Institute. Thalassemia conditions can cause the body to make fewer healthy red blood cells and less hemoglobin, a protein that carries oxygen to all parts of the body and returns carbon dioxide to the lungs so it can be exhaled. Some patients with thalassemia require frequent transfusions of red blood cells to maintain an acceptable level of hemoglobin. Iron overload is common in these patients. Endi

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