Mortality In Mind: Survival Analysis Drove Esbriet, Ofev Reviews, If Not Labels
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Neither Esbriet sponsor InterMune nor Ofev sponsor Boehringer Ingelheim chose to follow FDA’s advice to use mortality as the primary endpoint for trials in IPF, but exploratory survival findings were nonetheless key to approval of both drugs – even though the mortality data barely appear in labeling.
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