9:35AM Vertex Pharm: Phase 3 study of KALYDECO in children ages 6 to 11 with a specific type of cystic fibrosis showed significant improvements in lung function and other measures of disease sustained through 48 weeks (VRTX) 37.28 -0.38 : Results from ENVISION showed that children who received KALYDECO experienced rapid and sustained improvements in lung function and other key measures of disease, including weight gain and a reduction in sweat chloride, throughout the 48-week study compared to those treated with a placebo. Patients in the study who received KALYDECO experienced a mean absolute improvement from baseline in lung function of 12.5 percentage points through week 24 and a mean relative improvement from baseline in lung function of 17.4 percent compared to placebo. Through 48 weeks, the mean absolute improvement in lung function for children treated with KALYDECO was 10 percentage points compared to placebo and the relative mean improvement was 15.1 percent from baseline compared to placebo. Phase 3 results and product labeling for currently available CF medicines generally describe relative improvements in lung function. The most commonly reported adverse events were respiratory in nature and comparable across treatment groups
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