Vertex receives CHMP positive opinion for Orkambi in children with CF
Vertex Pharmaceuticals announced that the European Union Committee for Medicinal Products for Human Use issued a positive opinion recommending extension of the Marketing Authorization for ORKAMBI to children with cystic fibrosis ages 6 through 11 who have two copies of the F508del mutation. There are approximately 3,400 patients ages 6 through 11 eligible for this medicine in Europe. The European Commission generally follows the recommendations of the CHMP and typically extends the Marketing Authorization within three months. In some countries, Vertex said it has in place existing agreements that will make ORKAMBI available to this age group immediately following Marketing Authorization. In other countries, Vertex will begin the country-by-country reimbursement process following Marketing Authorization.