From Europe, Vertex (VRTX) was informed that the European Commission has granted an extension of the Marketing Authorization for ORKAMBI® (lumacaftor/ivacaftor).
Orkambi is for cystic fibrosis (CF) in people with two copies of the F508del mutation, including children ages 6 through 11
Reimbursement: In countries such as Ireland, reimbursement agreements will lead to rapid access to ORKAMBI. In other countries across the European Union, Vertex will begin a country-by-country reimbursement process.
Clinical trial Results demonstrated statistically significant