The FDA has expanded the indication for combination tezcaftor/ivacaftor tablets to include treatment of cystic fibrosis in children aged 6 years and older who have certain genetic mutations in the gene, according to an agency press release.
Before expanding the indication, tezcaftor/ivacaftor (Symdeko, Vertex Pharmaceuticals) was approved to treat cystic fibrosis only in children aged 12 and older who have two copies of the F508del mutation in the CFTR gene or who have at least one of the mutations in the CFTR gene that is responsive to the active ingredients in the drug based on in vitro data or clinical evidence.
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