> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Vertex Pharma’s Kalydeco Gains Expanded Indication
- URL: https://www.fdaweb.com/vertex-pharmas-kalydeco-gains-expanded-indication/
- Published: 2020-09-25T12:00:00.000Z
- Updated: 2026-09-14T16:30:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147737

FDA has approved Vertex Pharmaceuticals’ Kalydeco (ivacaftor) for use in children with cystic fibrosis (CF) ages four months to less than six months old who have at least one mutation in their cystic fibrosis transmembrane conductance regulator gene that is responsive to KALYDECO based on clinical or *in vitro* assay data. Kalydeco is already approved in the U.S. for treating CF in patients ages six months and older. Approval was based on data from the 24-week Phase 3 open-label safety cohort (ARRIVAL) in six affected children.