Vertex received European approval for CF drug Kalydeco

US biotech firm Vertex Pharmaceuticals (Nasdaq: VRTX) has announced that the European Commission has approved Kalydeco (ivacaftor) for people with cystic fibrosis aged six and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

The 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 the EC 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.

Simon Bedson, senior vice president and international general manager at Vertex, said: “Today's approval in people with additional gating mutations marks another step toward our goal of helping more people with this disease. We are committed to working closely with the appropriate national authorities to make Kalydeco available for these patients as soon as possible.”