Novartis’ New Drug Application for Exjade (deferasirox) has been granted priority review by the US FDA as a once-daily oral iron chelator for the treatment of chronic iron overload due to blood transfusions.

A priority review establishes an action date no later than six months after the submission date, which for Exjade was in May 2005. At that time, Novartis also submitted registration applications for Exjade in the European Union, Switzerland and Australia. Exjade, also known as investigational agent ICL670, has also been granted priority review in Australia and fast track status in Switzerland. Further, Exjade has received Orphan Drug status in the US, EU and Australia.

Diane Young, vice president, global head, Clinical Development, Novartis Oncology says, "We hope that once Exjade becomes available as a treatment option, it will not only improve the quality of life of those patients who for years have endured the discomfort of deferoxamine, but will also provide a new and acceptable treatment option for those who have been risking their lives by avoiding chelation therapy altogether because of the burdensome nature of the current standard of care."

Iron overload is a potentially life-threatening condition that results from frequent blood transfusions required to treat certain types of anaemias and other disorders, including thalassemia, sickle cell disease, other rare anaemias and myelodysplastic syndromes. If left undiagnosed or untreated, iron overload can lead to damage to the liver, heart and endocrine glands, and can be fatal. Transfused patients are often treated for iron overload with a type of drug therapy called iron chelation, which removes excess iron from the body.