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
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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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.
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