Novartis announces FDA approval for Jadenu to simplify treatment administration for patients with chronic iron overload

FDA

Novartis announced today that the US Food and Drug Administration 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 in patients 10 years of age and older. Jadenu is the only once-daily oral iron chelator that can be swallowed whole. 

Many patients with sickle cell disease, thalassemia or myelodysplastic syndromes need repeated blood transfusions and consequently, long-term daily chelation therapy. Jadenu oral tablets can be taken in a single step, with or without a light meal, simplifying administration of treatment for chronic iron overload. Exjade is a dispersible tablet that must be mixed in liquid and taken on an empty stomach. 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.

For more details, go to: http://www.novartis.com/newsroom/media-releases/en/2015/1907710.shtml

Michael Wonder

Posted by:

Michael Wonder

Posted in: