Vertex
Pharmaceuticals Incorporated VRTX today announced that the
European Commission has approved expansion of the indication for KALYDECO®
(ivacaftor) to include children ages 2 to 5 with cystic fibrosis (CF)
who have one of nine gating mutations in the cystic fibrosis
transmembrane conductance regulator (CFTR) gene (G551D, G1244E,
G1349D, G178R, G551S, S1251N, S1255P, S549N and S549R) and to include
people with CF ages 18 and older who have an R117H mutation. Ivacaftor
was previously approved in the European Union (EU) for use in people
with CF ages 6 and older who have one of nine gating mutations. In
Europe, approximately 125 children with CF ages 2 to 5 have one of the
nine gating mutations included in today's approval and approximately 350
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