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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Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile. If you do not have access, contact customer care at 1-800-332-2181 for a free copy of any of these articles.
Regulatory Round-Up: Drug Review Profiles From 2012
Each month, Pharmaceutical Approvals Monthly analyzes the FDA review process for a recent approval based on the NDA or BLA review documents. A detailed chronology of product development and listing of key reviewers accompany each profile.