European Commission approval for Kalydeco to treat infants with cystic fibrosis ages 1 month and older.- Vertex.
Vertex Pharmaceuticals announced that the European Commission has granted approval for the label expansion of Kayydeco (ivacaftor) for the treatment of infants down to 1 month of age with cystic fibrosis (CF) who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.