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# Vertex sNDA Seeks Trikafta Expanded Use
- URL: https://www.fdaweb.com/vertex-snda-seeks-trikafta-expanded-use/
- Published: 2021-01-26T12:00:00.000Z
- Updated: 2026-09-14T16:44:11.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148523

FDA has accepted for priority review a Vertex Pharmaceuticals supplemental NDA to expand the use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children ages six through 11 years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation in the CFTR gene that is responsive based on *in vitro* data. Currently, the therapy is approved for treating cystic fibrosis patients aged 12 years and older. The agency has set a user fee review action target date of 6/8.