By SPC News Staff
The FDA approved tezacaftor-ivacaftor (Symdeko, Vertex) for treating the underlying cause of cystic fibrosis (CF) in patients with certain genetic mutations.
The medication is indicated for people aged 12 years and older with two copies of the F508del mutation in the CF transmembrane conductance regulator (CFTR) gene or who have at least one mutation that is responsive to tezacaftor-ivacaftor.
The FDA granted approval based on the results of two phase 3 studies of