Posted by Michael Wonder on 10 Jan 2018
Vertex receives expanded EU approval for Orkambi (lumacaftor/ivacaftor) in children ages 6-11 years
10 January 2018 - Existing reimbursement agreements in countries like Ireland will enable rapid access to Orkambi; country-by-country reimbursement processes will now begin in other countries.
Vertex today announced that the European Commission has granted extension of the marketing authorisation for Orkambi (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people with two copies of the F508del mutation, to include children ages 6 through 11. In Europe, there are approximately 3,400 children ages 6 through 11 with two copies of this mutation.
Existing reimbursement agreements in countries such as Ireland will enable rapid access to Orkambi for these children. In other countries across the European Union, Vertex will now begin the country-by-country reimbursement process.
