FDA to review licence extension for elexacaftor/tezacaftor/ivacaftor and ivacaftor for additional CFTR mutations

FDA has accepted three supplemental New Drug Applications to extend the licences of these products to include additional CFTR mutations, based on in vitro data from a validated cell assay model showing that 30 rare mutations in the CFTR gene are responsive to these treatments.

Source:

Biospace Inc.