Kalydeco® (ivacaftor) – Expanded indication
August 15, 2018 - Vertex announced the FDA approval of Kalydeco (ivacaftor) for the treatment of cystic fibrosis (CF) in patients age 12 months and older who have one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data.
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