FDA approves ApoPharma's Ferriprox to treat patients with iron overload

The US Food and Drug Administration on Friday approved Ferriprox (deferiprone), from ApoPharma, a subsidiary of Canadian generics major Apotex, to treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy.

The decision comes despite pleas to the FDA from the US advocacy group Public Citizen to not approve Ferriprox, which it claimed failed to demonstrate that it is safe and effective in the intended patient population and pointed out that the agency had refused clearance in November 2009 due to insufficient evidence of safety and efficacy (The Pharma Letter October 13).

The standard of care to treat transfusional iron overload is chelation therapy – chemical agents that are used to remove heavy metals from the body. Ferriprox is intended for use when chelation therapy is inadequate.