ApoPharma's Ferriprox Clears FDA, But Needs Cardiac Safety Study
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 Ferriprox Clears ODAC Based In Part On Dosing Convenience
Approved thalassemia treatments are "onerous" compared to Ferriprox, which has been marketed in Europe for 12 years.
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.