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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
About this update from Vertex Pharmaceuticals Incorporated
[{"type":"text","content":"\n-Phase 3 study met primary endpoint and all secondary endpoints-\n\n\n-Study is a U.S. post-marketing commitment and will be submitted to FDA-\n\n\n-Data also will be submitted to the European Medicines Agency to support indication expansion of the EU label following triple combination approval-\n\n BOSTON--(BUSINESS WIRE)--\nVertex 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","length":1627,"tagName":"div"}]