28 April 2021 - New indication includes people ages 12 years and older who have one copy of the F508del mutation regardless of the other mutation type.
Vertex Pharmaceuticals today announced that the European Commission has granted approval of the label extension for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor for the treatment of cystic fibrosis in all patients ages 12 years and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator gene.