FDA Provides Accelerated Approval to Novartis’ Jadenu

The US Food and Drug Administration (FDA) recently approved a new, simplified formulation of Novartis’ Exjade (deferasirox) for the treatment of chronic iron overload.

The company said that the agency approved its Jadenu (deferasirox) tablets for oral suspension for the treatment of chronic iron overload due to blood transfusions in patients two years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes (NTDT) in patients ten years of age and older. The drug received accelerated approval for these indications based on reduction of liver iron concentration and serum ferritin levels. Continued approval for this indication may be contingent upon results from confirmatory trials.

Chronic iron overload is a life-threatening cumulative toxicity that results from blood transfusions used to treat sickle cell disease, myelodysplastic syndromes, thalassemia, and other conditions. It can occur in patients with NTDT due to increased iron absorption in the stomach and intestines. The condition, if left untreated, can lead to lethal liver and heart damage.

Jadenu is Novartis’ new formulation of Exjade, which has been used in patients with chronic iron overload for almost ten years. It is currently the most-prescribed chelator in the US, generating $926 million in sales in 2014. Exjade is a dispersible tablet that must be mixed in liquid and taken on an empty stomach. Jadenu simplifies administration. It can be taken in a single step, with or without a light meal.

“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 respond 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 said that it has submitted additional regulatory applications for Jadenu in other countries worldwide.

“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.”

Source: Novartis

Last updated: 4/2/15; 9:20am EST

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