European Commission approves licence extension for Symkevi (tezacaftor/ivacaftor) with Kalydeco (ivacaftor) for treatment of cystic fibrosis in patients ages 6 years and older with specific gene mutations
Approval is for children with 2 copies of F508del mutation in CFTR gene or 1 copy of F508del mutation and 1 copy of 1 of 14 mutations in CFTR gene that result in residual CFTR activity.
Source:
Biospace Inc.