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Source - The U.S. Food and Drug Administration (FDA) – The FDA has approved Exjade (deferasirox), an oral iron chelator developed to treat chronic iron overload due to multiple blood transfusions.
Exjade is the first orally administered medication to be approved for this use. Treatment for iron overload, which can damage the heart
and liver, had previously required daily prolonged drug infusions lasting 8-12 hours.
Exjade was approved under FDA's accelerated approval program, which allows FDA to approve products for serious or life-threatening
diseases based on early evidence of the product's effectiveness. Companies are required to do further studies to verify the clinical benefits. In clinical studies of 48 weeks duration, Exjade
demonstrated reduction in liver iron concentration in adult and pediatric patients receiving red blood cell transfusions on an ongoing basis.
Exjade also received Orphan Drug Designation, which is granted to products that treat diseases affecting fewer than 200,000 people in
the U.S. The Orphan Drug Act provides a seven-year period of exclusive U.S. marketing to the first sponsor that obtains marketing approval for a designated orphan drug.
Exjade is manufactured by Novartis Pharmaceutical Corp. in Stein, Switzerland.
This product is not licensed in the United Kingdom
For more information go to: http://WWW.FDA.GOV/BBS/TOPICS/NEWS/2005/new01258.html
Prepared by Susan Wileman Medicines Information Technician
Date of Preparation: 18th November 2005
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