Vertex Pharma Granted Extension Of Marketing Authorization For ORKAMBI In Europe

(RTTNews) - Vertex Pharmaceuticals Incorporated (VRTX) announced the European Commission has granted extension of the Marketing Authorization for ORKAMBI (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis in people with two copies of the F508del mutation, to include children ages 6 through 11. The European Commission's decision is based on data from two Phase 3 studies of ORKAMBI.

Simon Bedson, Senior Vice President and International General Manager at Vertex, said: "The long-term agreements we have reached in countries like Ireland will enable eligible children to have rapid access to ORKAMBI. Where these agreements are not in place, Vertex is committed to working with local authorities so those who could benefit from this medicine are able to do so as quickly as possible."