Novartis has filed regulatory submissions for Exjade (deferasirox), the first and only once-daily oral iron chelator for the treatment of chronic iron overload due to blood transfusions, in the United States and the European Union (EU).

Exjade, also known as investigational agent ICL670, has been granted fast-track status in the US and Switzerland. Priority review has been requested in the US. Furthermore, Exjade has received Orphan Drug status in the US, EU and Australia.

Exjade was developed to extend the benefits of iron chelation to a greater number of patients receiving blood transfusions and to address the needs of thousands of adult and paediatric patients who have been using Desferal (deferoxamine), a Novartis release said here.

"Novartis has demonstrated a long-term commitment to help improve the lives of patients at risk for iron overload. First by developing a highly effective drug, deferoxamine, and then by conducting research on hundreds of new compounds to find an easy-to-take oral alternative to this product." said Diane Young, vice president and global head of Clinical Development at Novartis Oncology.

Iron overload is a life-threatening cumulative toxicity which results from lifesaving blood transfusions required to treat certain types of anaemias and other disorders, including thalassemia, sickle cell disease, other rare anaemias, and myelodysplastic syndromes.