On Apr. 26, 2023, Vertex announced the Food and Drug Administration (FDA) had approved the expanded use of TRIKAFTAﾮ (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages 2 through 5 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive to TRIKAFTAﾮ based on in vitro data.

TRIKAFTAﾮ was previously approved by the FDA for use in people with CF 6 years and older with at least one F508del mutation or a mutation in the CFTR gene that is responsive to TRIKAFTAﾮ based on in vitro data.