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BioPharmaceutical United States Advisory Committees

Breo Ellipta Review Pits Clinical Benefits Against Statistical Shortcomings

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Executive Summary

FDA advisory committee majority favored approval of GlaxoSmithKline’s fluticasone furoate/vilanterol combination for COPD despite the failure, under a prespecified statistical analysis plan, to demonstrate significant results on all primary endpoints. GSK is developing the drug with Theravance.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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