Novartis drug to treat iron overload gets US nod
pharmafile | March 31, 2015 | News story | Sales and Marketing |Â Â FDA, Novartis, blood, deferasirox, exjade, iron, jadenuÂ
Novartis’ iron overload drug Jadenu has been given the green light by US regulators to treat patients with a serious chronic condition which is known to lead to diabetes and arthritis.
The FDA has approved Jadenu (deferasirox) for the treatment of iron overload often caused by blood transfusions, and the genetic disorder non-transfusion-dependent thalassemia syndrome (NTDT).
Jadenu, a new formulation of iron chelation therapy Exjade (deferasirox), is the only once-daily oral tablet for the illness which can also affect people with sickle cell disease, thalassemia and blood disorder myelodysplastic syndrome.
Many patients with these diseases need repeated blood transfusions and consequently, long-term daily chelation therapy. Jadenu can be taken with or without a light meal, simplifying administration of treatment for the condition, the firm says.
Bruno Strigini, who is the president of oncology at Novartis, says: “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.”
The drug’s indications are approved under accelerated approval based on a reduction of iron levels in the liver and blood which is measured by serum ferritin levels.
“Jadenu is an exciting development for patients with chronic iron overload who have been eager for alternative treatment options,” adds Dr Elliott Vichinsky, who is the director of haematology and oncology at the University of California and the Benioff Children’s Hospital in Oakland – and a professor at UCSF School of Medicine.
“Taking iron chelation therapy every day has sometimes been a challenge for patients. The administration of Jadenu oral tablets once a day is simple.”
Chronic iron overload is a life-threatening cumulative toxicity and if left untreated can damage the liver and heart. Symptoms resulting from too much iron include fatigue, joint pain, hair loss and infertility.
Novartis has submitted additional regulatory applications for the drug in other countries worldwide.
Tom Robinson
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