Kalydeco, the first Cystic Fibrosis drug of Vertex, got approved for infants
The Food and Drug Administration has cleared Kalydeco drug of Vertex Pharmaceuticals for infants aged 12 to under 24 months. The approved drug treats the underlying cause of cystic fibrosis in children of this age with at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. In 2012, Kalydeco (ivacaftor) was the first FDA-approved drug to treat the CF in people with the disorder aged 6 and older who have at least one copy of the G551D mutation. Since then, Kalydeco has extended to cover children and adults aged 2 years and older who have one of 38 ivacaft...