Novartis blood iron reduction treatment receives FDA approval

The US Food and Drug administration (FDA) has approved a Novartis application to supply its new oral drug Exjade, used to treat excess iron in the blood of patients who have received blood transfusions for conditions such as anaemia.

Exjade was developed as an oral alternative as an alternative to Novartis’ current treatment Desferal, delivered by an infusion. Patients who receive blood transfers as a result of sickle cell anemia, myelodysplastic syndrome or other blood disorders are often at risk of iron overload, a potentially fatal condition that can overwhelm vital organs.

Both Exjade and Desferal bind to the iron to help excrete it, but Novartis officials say that patients are more likely to fail to take Desferal as it must be infused for eight to 12 hours daily.

“Until now, patients may have avoided the potentially life saving benefits of iron chelation because the standard therapy can be difficult to use,” David Epstein, head of Novartis’ oncology division told Reuters.

An FDA advisory panel support Exjade’s approval, but said that it remained concerned about possible harmful effects on the liver and kidneys. It also expressed concern about Exjade’s use in children younger than five, but Novartis now says that the FDA has approved the drug in patients as young as two years old.

© Adfero Ltd