Trikafta® (elexacaftor/tezacaftor/ivacaftor; ivacaftor) – Updated label, boxed warning added
December 20, 2024 - Vertex announced the FDA approval of the expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor; ivacaftor) for the treatment of people with cystic fibrosis (CF) ages 2 and older who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation that is responsive to Trikafta based on clinical and/or in vitro data.