Positive Phase 3 Study Results for TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in People Ages 12 and Older With Cystic Fibrosis Who Have One Copy of the F508del Mutation and One Gating or Residual Function Mutation

-Phase 3 study met primary endpoint and all secondary endpoints-

-Study is a U.S. post-marketing commitment and will be submitted to FDA-

-Data also will be submitted to the European Medicines Agency to support indication expansion of the EU label following triple combination approval-

BOSTON--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results of a global Phase 3 study of TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in people with cystic fibrosis (CF) ages 12 years and older who have one copy of the F508del mutation and one gating mutation (F/G) or one copy of the F508del mutation and one residual function mutation (F/RF). The study met its primary endpoint of mean absolute within-group change in percent predicted forced expiratory volume in 1 second (ppFEV1) from baseline through 8 weeks of treatment, demonstrating a statistically significant 3.7 percentage point (p