European Commission Grants Vertex’s Cystic Fibrosis Therapy Expanded Approval

Vertex Pharmaceuticals’ combination therapy Symkevi (tezacaftor/ivacaftor)/Kalydeco (ivacaftor) has received European Commission approval for treating children aged six and up with cystic fibrosis.

The expanded approval now allows the combination treatment to be used to treat cystic fibrosis in patients six years of age and older that have the F508del mutation in the cystic fibrosis transmembrane conductor (CFTR) gene, the most common cause of the genetic disease.

The combination was already approved in Europe for treating cystic fibrosis patients aged 12 and older with the F508del mutation.