Approximately 4,000 people living with CF in the European Union are newly eligible for a medicine that treats the underlying cause of their disease for the first time.
Vertex Pharmaceuticals has announced 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 two years and older who have at least one non-class I mutation in the cystic fibrosis conductance regulator (CFTR) gene.
As a result of existing Kaftrio reimbursement agreements in Austria, Denmark, Ireland, Norway and Sweden, and provisions for access in health care systems such as Germany, eligible patients in these countries will have access to the expanded indication of the therapy shortly.
Vertex will continue to work collaboratively with reimbursement authorities across the European Union to ensure access for all eligible patients, as quickly as possible.
