Vertex’s Kaftrio Nabs EU Approval as Combination Treatment for Cystic Fibrosis

Vertex Pharmaceuticals has secured an expanded indication in the EU for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with additional ivacaftor for treating patients with certain mutations in the cystic fibrosis transmembrane conductance regulator gene.

Approval was supported by positive results from three global phase 3 studies enrolling 768 cystic fibrosis patients.  

The triple combination therapy plus ivacaftor was previously approved for this indication in the U.S. and Australia, where Kaftrio is marketed as Trikafta.