Vertex announced that the European Committee for Medicinal Products for Human Use has issued a positive opinion recommending the approval of KALYDECO for people with cystic fibrosis ages 6 and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator gene. The CHMP opinion is based on previously announced data from the first part of a Phase 3, two-part, randomized, double-blind, placebo-controlled, cross-over study of 39 people with CF ages 6 and older who have a non-G551D gating mutation. The first part of the study showed statistically significant improvements in lung function, sweat chloride, BMI and CFQ-R scores. Data from the second part of the study were presented at the European Cystic Fibrosis Society Conference and showed that these improvements were maintained through 24 weeks of treatment with ivacaftor. The safety profile was similar to prior Phase 3 studies of ivacaftor in people with the G551D mutation. The CHMP's positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the E.U. The European Commission generally follows the recommendation of the CHMP and typically issues marketing approval within three to four months. The CHMP also issued a positive opinion recommending the inclusion of data from the long-term follow-up PERSIST study in the KALYDECO label