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Kalydeco® (ivacaftor) – Expanded indication

May 17, 2017 – The FDA announced the approval of Vertex’s Kalydeco (ivacaftor) for the treatment of cystic fibrosis (CF) in patients age 2 years 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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