LONDON–(BUSINESS WIRE)–Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced that the Spanish Government has approved terms for the national reimbursement of ORKAMBI® (lumacaftor/ivacaftor) and SYMKEVI® (tezacaftor/ivacaftor) in combination with KALYDECO® (ivacaftor) for eligible patients in Spain living with cystic fibrosis (CF).
Under the terms announced today, children ages 6 to 11 years with CF who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene can be treated with ORKAMBI. Patients ages 12 years and older who either have two copies of the F508del mutation, or one copy of the F508del mutation and a copy of one of the other 14 mutations approved within the license in which the CFTR protein shows residual activity, can be treated with SYMKEVI in combination with KALYDECO.
Ludovic Fenaux, Senior Vice President, Vertex International, commented, “Today’s announcement means ORKAMBI and SYMKEVI can be prescribed from the first of November 2019 for the approximately 600 eligible cystic fibrosis patients living in Spain, to treat the underlying cause of their disease. We thank the Spanish Authorities for their collaboration and commitment to working with us in an innovative way to come to a solution for patients. We would also like to acknowledge the medical community for their important input during this process.”
Vertex’s CF medicines are reimbursed in 17 countries around the world including Austria, Australia, Denmark, Germany, the Republic of Ireland, Italy, the Netherlands, Sweden and the U.S.