European Commission extends approval of Kalydeco in Cystic Fibrosis - Vertex Pharma

Vertex Pharmaceuticals Incorporated announced that the European Commission has approved Kalydeco (ivacaftor) for people with Cystic Fibrosis (CF) ages 6 and older who have one of eight non-G551D gating mutations in the Cystic Fibrosis transmembrane conductance regulator (CFTR) gene. This approval follows the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in June 2014. Kalydeco was first approved in Europe in July 2012 for people with CF ages 6 and older who have the G551D mutation, which is the most common gating mutation. The eight additional gating mutations included in today's approval are: G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P and G1349D. In Europe, approximately 250 people ages 6 and older have one of these non-G551D gating mutations.