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Orkambi® (lumacaftor/ivacaftor) – Expanded indication, new strength

September 2, 2022 - Vertex announced the FDA approval of Orkambi (lumacaftor/ivacaftor), for the treatment of cystic fibrosis (CF) in patients aged 1 year and older who are homozygous for the F508del mutation in the CFTR gene. If the patient’s genotype is unknown, an FDA-cleared CF mutation test should be used to detect the presence of the F508del mutation on both alleles of the CFTR gene.

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