FDA Approves Novel Treatment for Chronic Iron Overload

Novartis announced the US Food and Drug Administration (FDA) has approved Jadenu (deferasirox), a simplified treatment method for patients with chronic iron overload.

A new formulation of Exjade (deferasirox), Jadenu is the only once-daily oral iron chelator for the treatment of chronic iron overload resulting from blood transfusions in patients 2 years and older as well as chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years and older.

Many patients with myelodysplastic syndromes, sickle cell disease or thalassemia need consistent blood transfusions and, in turn, long-term daily chelation therapy. However, Jadenu oral tablets can be taken in a single step, with or without a light meal, thereby simplifying administration.

Bruno Strigini, President, Novartis Oncology, said, “Exjade transformed iron chelation therapy. We responded to feedback from patients and their physicians, and now Jadenu, by simplifying treatment administration, offers an important new option to help meet these patients’ needs."

Jadenuwas approved under accelerated approval as a result of reduction of liver iron concentrations and serum ferritin levels, and is currently available by prescription-only in the US.

“Jadenu is an exciting development for patients with chronic iron overload who have been eager for alternative treatment options,” said Elliott Vichinsky, MD, Director of Hematology and Oncology, University of California, San Francisco (UCSF) Benioff Children's Hospital Oakland and Professor, UCSF School of Medicine. “Taking iron chelation therapy every day has sometimes been a challenge for them. The administration of Jadenu oral tablets once a day is simple.”