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CV Outcomes and Anoro: An Excerpt From The Summary Review

This article was originally published in RPM Report

Executive Summary

Here is Office of Drug Evaluation II Director Curtis Rosebraugh’s discussion of the decision not to require a cardiovascular outcomes trial for GlaxoSmithKline/Theravance’s Anoro Ellipta (umeclidinium/vilanterol or UMEC/VI) combination inhaler for COPD. The memo is date December 18 and was discussed during the Feb. 12 FDA/IoM workshop on “uncertainty” in risk/benefit analyses.

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