Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload

Novartis International AG / Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Jadenu (deferasirox), a new formulation of Exjade (deferasirox), is the only once-daily oral tablet for iron chelation
   

Jadenu, taken with or without food, simplifies daily treatment administration for patients with chronic iron overload
 

Chronic iron overload is a serious condition that can affect people with sickle cell disease, thalassemia and myelodysplastic syndromes

Basel, March 30, 2015 - Novartis announced today that the US Food and Drug Administration (FDA) has approved Jadenu^TM (deferasirox) tablets, a new oral formulation of Exjade^® (deferasirox) tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years of age and older. Jadenu is the only once-daily oral iron chelator that can be swallowed whole.

Many patients with sickle cell disease, thalassemia or myelodysplastic syndromes need repeated blood transfusions and consequently, long-term daily chelation therapy. Jadenu oral tablets can be taken in a single step, with or without a light meal, simplifying administration of treatment for chronic iron overload. Exjade is a dispersible tablet that must be mixed in liquid and taken on an empty stomach. Jadenu is approved under accelerated approval based on a reduction of liver iron concentrations and serum ferritin levels. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

"Novartis has had a long-term commitment to improving the lives of patients with chronic iron overload," said Bruno Strigini, President, Novartis Oncology. "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."