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.