Vertex Pharmaceuticals announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label expansion of KAFTRIO (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor. This expansion is for the treatment of people with cystic fibrosis (CF) aged 2 years and older.
The expanded indication includes patients who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. If approved by the European Commission, this will make approximately 4,000 additional people with CF in the European Union eligible for a CFTR modulator for the first time.
This positive opinion is a crucial step towards broadening access to KAFTRIO across Europe. It underscores Vertex's commitment to bringing treatments that address the underlying cause of CF to a wider patient population.
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