Vertex Pharmaceuticals announced that the European Commission has granted regulatory approval for a label expansion of KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor. This approval expands the indication to include all patients aged 2 years and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
This regulatory decision makes approximately 4,000 additional people living with CF in the European Union newly eligible for a medicine that treats the underlying cause of their disease for the first time. This significantly broadens the addressable patient population for KAFTRIO.
Eligible patients in countries with existing reimbursement agreements, such as Austria, Denmark, Ireland, Norway, and Sweden, and those with access provisions like Germany, are expected to gain access to the expanded indication shortly. Vertex will continue to work with reimbursement authorities across the EU to ensure broad patient access.
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