Exjade deferasirox regulatory update

EMA's CHMP issued a positive opinion recommending expanding the label of Exjade deferasirox to include treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients >=10 years of age with non-transfusion-dependent thalassemia. An sNDA is under review in the U.S. for Exjade in the expanded indication. Novartis expects a decision in 1Q13 for the sNDA; the PDUFA date is not disclosed. ...