CHMP recommends licence extension for ivacaftor (Kalydeco)

Ivacaftor is now intended to be licensed in a combination regimen with tezacaftor and elexacaftor for patients aged 12 and older with cystic fibrosis who are homozygous for the F508del mutation in or heterozygous for F508del in the CFTR gene with a minimal function mutation.


European Medicines Agency