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BioPharmaceutical United States Advisory Committees

Kalydeco Label Expansion Could Set New Precedent On FDA Flexibility

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Executive Summary

Agency must decide whether to approve for cystic fibrosis patients with R117H mutation even though the pivotal trial failed and age-related subgroup analyses produced conflicting results. Vertex picked up an advisory committee endorsement despite panelists’ concerns about suboptimal results in pediatric patients.

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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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