BI’s Tradjenta Lesson: Don’t Try To Use CV Trial To Score Head-To-Head Efficacy Evidence
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Boehringer Ingelheim GmbH saw an opportunity to gather more and better head-to-head data for anti-diabetic Tradjenta in its post-market cardiovascular outcomes trial, but FDA couldn't picture a better comparator than gold-standard placebo.