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 aged 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.
About Vertex
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia and acute pain, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, primary membranous nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1.
