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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.

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