31 October 2019 - Application supported by positive results from two global Phase 3 studies in people with cystic fibrosis ages 12 and older with one F508del mutation and one minimal function mutation and in people with two F508del mutations.

Vertex Pharmaceuticals today announced that the European Medicines Agency (EMA) has validated the marketing authorisation application for the VX-445 (elexacaftor), tezacaftor and ivacaftor triple combination regimen. 

The submission was supported by previously disclosed positive results of two global Phase 3 studies in people with cystic fibrosis: a 24-week study in people with one F508del mutation and one minimal function mutation and a 4-week study in people with two F508del mutations.

Read Vertex Pharmaceuticals press release