Vertex Pharmaceuticals announced that the European Medicines Agency’s, or EMA’s, Committee for Medicinal Products for Human Use, or CHMP, adopted an opinion for the label expansion of Kalydeco for the treatment of infants with cystic fibrosis, or CF, ages one month to less than four months old who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator gene: R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
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