Vertex Pharma Granted Label Extension For KALYDECO In EU - Quick Facts

(RTTNews) - Vertex Pharmaceuticals (Europe) Limited announced the European Commission has granted approval of the label extension for KALYDECO (ivacaftor) to include the treatment of people with cystic fibrosis aged 12 to <24 months who have at least one of the following nine mutations in their cystic fibrosis transmembrane conductance regulator gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. Ivacaftor is already approved in Europe for the treatment of CF in patients aged two years and older who have one of the nine mutations in the CFTR gene.

"For the first time, EU physicians can now treat the underlying cause of CF earlier than ever, helping to improve clinical outcomes in children as young as 12 months," said Reshma Kewalramani, Executive Vice President, Global Medicines Development and Medical Affairs and Chief Medical Officer at Vertex.