THE US Food & Drug Administration has granted approval for ivacaftor (Kalydeco) to be used to treat cystic fibrosis patients aged one month to less than four years of age who have at least one mutation in their CF transmembrane conductance regulator (CFTR) gene that is responsive to ivacaftor.
Previously, the product was approved for patients aged four months and over, with ivacaftor now the first and only CFTR modulator approved for infants as young as one month old.
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