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EU approves Symkevi + Kalydeco for eligible children with cystic fibrosis.- Vertex

Read time: 1 mins

Published:28th Nov 2020

The European Commission has approved Symkevi (tezacaftor/ivacaftor) with Kalydeco (ivacaftor), from Vertex, for eligible children with cystic fibrosis (CF) aged 6-11 years. The combination therapy offers a treatment option for CF patients who are homozygous for F508del in this age group, and is the only medicine to treat the underlying cause of CF in this patient group. Approval includes use of the combination in patients aged six years and older who have two copies of the F508del mutation in the CF 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.

Condition: Cystic Fibrosis-F508del-gene

Type: drug

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