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).
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Regulatory approval.
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.
“We have been working for years to bring treatment options to all people with cystic fibrosis, including those with ultra rare mutations,” said Carmen Bozic, M.D., executive vice president, global medicines development and medical affairs, and chief medicalofficer, Vertex. “We are pleased that the European Commission has broadened the KAFTRIO indication to include all CF patients 2 years and older who have at least one non-class I mutations, ensuring that even more people living with CF can benefit from this transformative medicine.”
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.
Vertexwill continue to work collaboratively with reimbursement authorities across the European Union to ensure access for all eligible patients, as quickly as possible.