European advisory group backs expanded label for Vertex’s Kalydeco

The European Medicines Agency’s advisory group CHMP has adopted a positive opinion recommending revised labeling for Vertex Pharmaceuticals’ (NASDAQ:VRTX) cystic fibrosis (CF) med Kalydeco (ivacaftor).

The new labeling, if approved by the European Commission (EC), includes the approval a new 25 mg strength and an extension to the existing indication to include infants at least six months old and weighing from 5 kg to less than 25 kg.

A final decision from the EC usually takes ~60 days.

https://seekingalpha.com/news/3506870-european-advisory-group-backs-expanded-label-vertexs-kalydeco