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ApoPharma's Ferriprox Clears FDA, But Needs Cardiac Safety Study

Executive Summary

FDA's Oct. 14 accelerated approval of ApoPharma's second-line oral iron chelation therapy Ferriprox (deferiprone) includes a requirement that the sponsor conduct a post-marketing QT prolongation study, which the agency did not mention in background documents before the key advisory panel vote.

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ApoPharma's Preemptive Safety Strategy For Ferriprox Includes Centralized Pharmacy Distribution

ODAC will consider Ferriprox (deferiprone) as second-line treatment for transfusional iron overload; the company hopes for an endorsement of its patient and provider registries as well.

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