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FDA approves Jadenu for chronic iron overload
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The FDA announced the approval of Jadenu tablets for the treatment of certain patients with chronic iron overload, according to a press release from the drug’s manufacturer.
Jadenu (deferasirox, Novartis) is intended for patients aged 2 years or older with chronic iron overload due to repeated blood transfusions and patients aged 10 years or older with chronic iron overload due to non-transfusion-dependent thalassemia syndromes. Jadenu received accelerated approval for these indications based on reduction of liver iron concentration and serum ferritin levels.
Jadenu — a new formulation of Exjade (deferasirox, Novartis) — is the only once-daily oral tablet for iron chelation that can be swallowed whole. Unlike Jadenu, which can be taken in a single step with or without a light meal, Exjade must be mixed in liquid and taken on an empty stomach.
Jadenu and Exjade contain the same active ingredient — deferasirox — which has been prescribed to patients with chronic iron overload for almost 10 years.
"Novartis has had a long-term commitment to improving the lives of patients with chronic iron overload," Bruno Strigini, PharmD, MBA, president of Novartis Oncology, said in a press release. "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."
Ongoing studies are evaluating how Jadenu works over a longer period of time.
The most common adverse events associated with Jadenu in clinical trials included nausea, vomiting, diarrhea, stomach pain, increases in kidney laboratory values and skin rash. It is not known whether or not Jadenu is effective in combination with other iron chelation therapy, according to the release.