FDA Approves Jadenu from Novartis to treat chronic iron overload

WASHINGTON - March 31, 2015 - PRLog -- The U.S Food and Drug Administration (FDA) has approved Novartis' Jadenu^TM (deferasirox) a once-daily oral iron tablet to treat chronic iron overload due to blood transfusions in patients 2 years and older and chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years of age and older. The Jadenu tablet can be swallowed whole and be taken with or without food thus simplifying the daily treatment administration for patients with this condition. Typically, patients who suffer from sickle cell disease, thalassemia or myelodysplastic syndromes need frequent blood transfusions and consequently have to undergo long term chelation therapy as seen with Exjade, a dispersible tablet that needs to be mixed with liquid and taken on an empty stomach.  Jadenu contains deferasirox, the same active ingredient that is in Exjade which is currently the most-prescribed chelator in the United States.

"Jadenu is an exciting development for patients with chronic iron overload who have been eager for alternative treatment options," said Dr. Elliott Vichinsky, Director of Hematology and Oncology at the 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."

Chronic iron overload is a life-threatening cumulative toxicity that results from blood transfusions required to treat sickle cell disease, myelodysplastic syndromes, thalassemia and other conditions and can cause serious damage to the liver and heart if left untreated. Jadenu received accelerated approval from the FDA based on a reduction of liver iron concentrations and serum ferritin levels. The treatment will still be assessed for continued approval for this indication based on further substantiation 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."

Novartis has already submitted regulatory applications for Jadenu in other countries worldwide.

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