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Breo Inverts Traditional Path To COPD Indication For LABA Combinations

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

GlaxoSmithKline’s NDA for Breo Ellipta sought a COPD indication without prior approval of the combination product or its individual inhaled corticosteroid and long-acting beta agonist components in asthma. A broad development program with extensive dose finding won over a skeptical FDA.

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