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Persistence, Secondary Endpoints Helped Shire Get FDA Nod For Firazyr Novel PRO

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA questioned the validity of icatibant’s patient-reported outcomes instrument during a first-cycle review and found it “difficult to interpret.” But conducting a third trial and running validity testing after FDA issued final PRO guidance, as well as key secondary endpoints that supported the treatment effect, helped sway regulators.

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