Trials & Filings

Vertex CF Treatment Misses Endpoint

Subset shows significant improvement in lung function

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Vertex Pharmaceuticals has posted data from a Phase III study of ivacaftor in 69 people 6 years of age and older with cystic fibrosis (CF) who have the R117H mutation. The trial missed its primary endpoint of the absolute change from baseline in FEV1 (percent predicted forced expiratory volume in one second, FEV1) throughout the treatment period for ivacaftor compared to placebo across all patients. In the study, the mean absolute treatment difference in the change from baseline in percent pred...

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