EU approves expansion of indication for Kalydeco (ivacaftor) in Cystic Fibrosis - R117H mutation, ages 18 and older- Vertex Pharmaceuticals

Vertex Pharmaceuticals announced that the European Commission has approved expansion of the indication for Kalydeco (ivacaftor) to include people with Cystic Fibrosis ages 18 and older who have an R117H mutation. The European Commission�s Decision is based on previously announced data from a Phase III study of ivacaftor that enrolled 69 people with CF who had an R117H mutation.