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ApoPharma's Ferriprox Clears ODAC Based In Part On Dosing Convenience

This article was originally published in The Pink Sheet Daily

Executive Summary

Approved thalassemia treatments are "onerous" compared to Ferriprox, which has been marketed in Europe for 12 years.

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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.

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.

ApoPharma's Ferriprox Gamble Pays Off In Panel Vote, But What About FDA?

ApoPharma's risky move in not complying with FDA's request for an additional randomized controlled trial of its iron overload treatment Ferriprox (deferiprone) paid off in a lopsided advisory panel vote in favor of approval, but the agency has yet to give the final word.

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