Ferriprox deferiprone regulatory update

FDA granted accelerated approved to an NDA from Apotex for Ferriprox to treat transfusional iron overload in patients with thalassemia when current chelation therapy is inadequate. The label includes a boxed warning about the risk of agranulocytosis, which may be preceded by neutropenia. Apotex plans to launch the iron chelating agent in the next three months.

As part of the approval, Apotex agreed to conduct a postmarketing trial of Ferriprox in patients with sickle cell disease who have iron overload. Apotex plans to begin the trial next year. ...