FDA advisors recommend approval of Ferriprox for Iron Overload

The FDA's Oncologic Drugs Advisory Committee has voted 10 - 2 to recommend that the FDA grant accelerated approval of Ferriprox (deferiprone), from ApoPharma. The drug is an oral iron chelator, for the treatment of patients with transfusional Iron Overload when current chelation therapy is inadequate. This can be vital for Thalassemia patients of whom approximately one quarter are not able to manage Iron Overload with currently available treatment. This can lead to organ failure and early death. The FDA is expected to act on the New Drug Application for Ferriprox by 14 October 2011, and although the agency usually follows ODAC recommendations, it is not obliged to do so.