Firazyr Efficacy Findings Were Muddied By Choice Of Comparator
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
A pivotal trial comparing Firazyr to an active comparator not approved by FDA helped bring about the first cycle “not approvable” decision. FDA’s cross-study comparison failed to show that tranexamic acid was no worse than placebo, so the trial could have made icatibant look better than it was. A third, placebo-controlled trial ultimately sealed the deal for approval.
You may also be interested in...
Case Studies In FDA's Regulatory Interpretation Of Clinical Trials
For more than 15 years, the Pink Sheet's Drug Review Profile series has looked closely at FDA approval documents, providing a long view of the pitfalls and pitches presented in the NEJM series on interpreting clinical trial results.
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. 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.