Posted by Michael Wonder on 28 Nov 2020
Vertex announces European Commission approval for Symkevi (tezacaftor/ivacaftor) with Kalydeco (ivacaftor) for eligible children with cystic fibrosis ages 6-11 years
27 November 2020 - The combination therapy is a new treatment option for CF patients who are homozygous for F508del.
Vertex Pharmaceuticals today announced that the European Commission has granted approval of the label extension for Symkevi (tezacaftor/ivacaftor) with Kalydeco (ivacaftor), to include the treatment of cystic fibrosis in patients ages 6 years and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or one copy of the F508del mutation and one copy of one of 14 mutations in the CFTR gene that result in residual CFTR activity: P67L, R117C, L206W, R352Q, A455E, D579G, 711+3A→G, S945L, S977F, R1070W, D1152H, 2789+5G→A, 3272-26A→G, and 3849+10kbC→T.
