Vertex announced that the FDA has approved Kalydeco (ivacaftor tablets) to treat cystic fibrosis (CF) in patients ≥6 years who have at least one copy of the G551D mutation in the cystic fibrosis transmembrane conductance regulator gene.

This approval was based on data from two Phase 3 studies of people with CF who have at least one copy of the G551D mutation. Those treated with Kalydeco experienced significant and sustained improvements in lung function as well as other disease measures, including weight gain and certain quality of life measurements, compared to those who received placebo. Patients who took Kalydeco also experienced significantly fewer pulmonary exacerbations.

Kalydeco is expected to be available later this week. It will be supplied in a 150mg dosage strength.

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