FDA approves Jadenu (deferasirox oral suspension) a new formulation of deferasirox to treat chronic iron overload-Novartis

Novartis announced that the FDA has approved Jadenu (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. 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.

Comment: Jadenu contains deferasirox, the same active ingredient as Exjade. Novartis developed this new formulation of deferasirox to help improve patient adherence to iron chelation therapy. The original formulation used in Exjade requires the patient to mix and drink the medication in a large glass of water or juice on an empty stomach. Jadenu contains the same active ingredient as Exjade in a formulation that can be taken in a single step and may be taken with a light meal, simplifying administration for patients and providing effective reduction of iron overload. Jadenu is a once-daily oral tablet that can be swallowed whole, with water or other liquid, and does not require dispersion in liquid like Exjade, offering a single-step treatment option. This means it can be taken without time-consuming preparation. Jadenu can also be taken with or without a light meal, while Exjade must be taken on an empty stomach.