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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P05-86
November 9, 2005

Media Inquiries:
Laura Alvey, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Approves First Oral Drug for Chronic Iron Overload

The U.S. Food and Drug Administration (FDA) announced today the approval of 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 provides a significant advantage to adults and children who suffer from iron overload due to multiple red cell transfusions. This oral therapy will allow greater patient compliance and will potentially reduce the complications of iron overload," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.

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.

In clinical studies, common side effects included nausea and abdominal pain. Elevations in blood tests that measure kidney and liver functions were also noted. Less common side effects included hearing and visual disturbances and rashes. Monitoring of laboratory tests measuring kidney and liver function and testing of hearing and vision before and during treatment are recommended.

Exjade is manufactured by Novartis Pharmaceutical Corp. in Stein, Switzerland.

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