FDA Approves Vertex's Kalydeco in Cystic Fibrosis Patients with Eight Additional Mutations | GenomeWeb

The US Food and Drug Administration last week approved Vertex Pharmaceuticals' Kalydeco (ivacaftor) for cystic fibrosis patients six and older who harbor one of eight mutations in the CFTR gene.

The FDA first approved Kalydeco in late 2012 for cystic fibrosis patients six and older who have at least one copy of the G551D mutation. In addition to this mutation, the drug is now approved for cystic fibrosis patients who have the G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P and G1349D mutations.

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