Data from a Phase III trial of Vertex Pharmaceuticals’ Kalydeco (ivacaftor) has been published ion the New England Journal of Medicine.
Kalydeco targets the defective protein responsible for cystic fibrosis.
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The STRIVE study evaluated 161 patients aged 12 or older who received at least one dose of either Kalydeco as a single 150mg tablet or placebo twice daily and showed improvements in lung function and other measures of disease throughout the 48-week study.
The study reported a 10.6% mean absolute improvement and 16.7% relative mean improvement in lung function from baseline compared to placebo through to week 24.
Through to week 48, the mean absolute improvement in lung function was 10.5% and the relative mean improvement was 16.9% from baseline compared to placebo.
The company has submitted a new drug application to the US Food and Drug Administration and a marketing authorisation application to the European Medicines Agency.
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