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BioPharmaceutical United States Advisory Committees

FDA Panel To Weigh Adequacy Of Efficacy Evidence For Kalydeco Label Expansion

This article was originally published in The Pink Sheet Daily

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Executive Summary

Vertex is seeking approval for cystic fibrosis patients ages six years and older with the R117H mutation despite the pivotal trial’s primary endpoint failure and unfavorable pediatric subgroup results. Company believes totality of evidence supports approval and pediatric efficacy can be extrapolated from positive adult subgroup findings.

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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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