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Phase IV Proof of Efficacy: A Brilinta Idea?

This article was originally published in RPM Report

Executive Summary

AstraZeneca won two strong votes in favor of approval of its clot-busting drug Brilinta (ticagrelor) from FDA's Cardio-Renal Drugs Advisory Committee on July 28. Standing between the drug and final FDA approval, however, is an unusual request from the advisory committee for a supporting Phase IV efficacy study in the same indication as approval. That's a sign of the troublesome advice that FDA is getting on post-maketing studies form advisory committees.

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