publication date: Apr. 3, 2015

FDA Approves Chelator Jadenu, an Oral Formulation of Exjade

 

FDA 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 contains the same active ingredient in Exjade. Exjade currently is the most-prescribed chelator in the U.S.

Novartis, Jadenu’s sponsor, has submitted additional regulatory applications for Jadenu in other countries worldwide.

Jadenu is an iron chelator indicated for the treatment of chronically elevated levels of iron in the blood caused by repeated blood transfusions (transfusional hemosiderosis) in patients ages 2 years and older. Jadenu is also indicated to treat patients ages 10 years and older who have chronic iron overload resulting from non-transfusion-dependent thalassemia.

These indications were approved under accelerated approval based on a reduction of iron levels in the liver (measured by liver iron concentration) and blood (measured by serum ferritin levels). Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. There are ongoing studies to find out how Jadenu works over a longer period of time.

 

FDA granted Priority Review to Kyprolis (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy. The agency also accepted the drug’s supplemental new drug application designed to support the conversion of accelerated approval to full approval and expand the current Kyprolis indication. FDA set a target action date of July 26.

The sNDA is … Continue reading 41-13 FDA Approves Chelator Jadenu, an Oral Formulation of Exjade

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