CFI welcome the announcement from Vertex Pharmaceuticals that the European Commission has granted regulatory approval for a label expansion of KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) in a combination regimen with ivacaftor for the treatment of people with Cystic Fibrosis (CF).
With this approval, the indication has been expanded to include all patients ages 2 years and older who have at least one non-class I mutation in the cystic fibrosis conductance regulator (CFTR) gene.
This approval follows a positive opinion for the label expansion adopted by the (EMA) Committee for Medicinal Products for Human Use (CHMP) on the 28th February 2025.
Sarah Tecklenborg CEO commented “The Access to Medication working group have been campaigning tirelessly for this extension and we are delighted with this development. This is the next significant step in the campaign to ensure that no person with CF is left behind.”
CFI will continue to bring updates to our members as we receive them.