EC approves expanded indication for cystic fibrosis treatment
The European Commission has approved the label extension for KALYDECO® (ivacaftor) to include the treatment of infants with cystic fibrosis between six and 12 months old.
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The European Commission has approved the label extension for KALYDECO® (ivacaftor) to include the treatment of infants with cystic fibrosis between six and 12 months old.
The application was supported by positive results from two global Phase III studies in people with cystic fibrosis aged 12 and older.
A new agreement will allow eligible cystic fibrosis patients in England to have access to CFTR modulators to treat the underlying cause of their disease.
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