Vertex Receives EU Approval For ORKAMBI - Quick Facts

(RTTNews) - Vertex Pharmaceuticals Inc (VRTX) announced the European Commission has granted Marketing Authorization for ORKAMBI (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis in people ages 12 and older who have two copies of the F508del mutation. The company said the approval is based on previously announced data from two 24-week global Phase 3 studies, TRAFFIC and TRANSPORT, and additional interim 24-week data from the subsequent extension study, PROGRESS, in people ages 12 and older who have two copies of the F508del mutation.

"The EU approval of lumacaftor in combination with ivacaftor is a major milestone in our longstanding efforts to develop new medicines that treat the underlying cause of the disease for people with cystic fibrosis," said Jeffrey Leiden, Vertex's CEO.