Two 24-Week Phase 3 Studies of Lumacaftor in Combination with Ivacaftor Met Primary Endpoint with Statistically Significant Improvements in Lung Function (FEV1) in People with Cystic Fibrosis who have Two Copies of the F508del Mutation
-Combination of lumacaftor and ivacaftor is the first regimen designed to treat the underlying cause of CF in people with two copies of the F508del mutation, the most common form of the disease-
-All four 24-week treatment arms achieved primary endpoint of mean absolute improvement in FEV1 compared to placebo, with a range of 2.6 to 4.0 percentage points (p≤0.0004); mean relative improvement of 4.3% to 6.7% (p≤0.0007)-
- Published: 24 June 2014
- Written by Editor