Novartis seeks approval for iron overload treatment

Exjade has already been granted fast-track status in the US and Switzerland. Priority review has been requested in the US. The treatment has also received Orphan Drug status in the US, EU and Australia.

Formally known as ICL670, Exjade (deferasirox), is the first and only once-daily oral iron chelator for the treatment of chronic iron overload. The water-soluble tablet binds the iron particles and removes them from the blood flow, benefiting thousands of blood transfusion patients in which the need for transfusion and chelation therapy may be life-long.

The new drug will replace Desferal, the current standard chelation therapy offered by Novartis, which typically requires subcutaneous infusion lasting eight to twelve hours per day, for five to seven days a week. The ease of administration offered by Exjade will benefit many patients, especially those who dislike needles for whom Desferal is particularly difficult. It is thought compliance with the therapy will increase as a result.

Analysts expect the drug to be launched in 2006, predicting inflated sales as a result of expanding patient populations.

Iron overload is a life-threatening cumulative toxicity which results from lifesaving blood transfusions required to treat certain types of anemias and other disorders, including thalassemia, sickle cell disease, other rare anemias, and myelodysplastic syndromes. If left undiagnosed or untreated, iron overload can lead to damage to the liver, heart and endocrine glands.