FDA to review TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 with certain mutations

This will be a review for a license extension for use in children 6-11. It is currently licensed in the US and EU for patients 12 years and over homozygous for the F508del mutation in the CFTR gene or heterozygous for F508del in the CFTR gene with a minimal function mutation.

Biospace Inc.