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# Priority Review for Vertex NDA for Cystic Fibrosis Therapy
- URL: https://www.fdaweb.com/priority-review-for-vertex-nda-for-cystic-fibrosis-therapy/
- Published: 2017-08-24T12:00:00.000Z
- Updated: 2026-09-14T22:43:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139468

FDA has accepted for priority review a Vertex Pharmaceuticals NDA for tezacaftor/ivacaftor combination use in people with cystic fibrosis ages 12 and older who have two copies of the *F508del* mutation or one *F508del* mutation and one residual function mutation that is responsive to tezacaftor/ivacaftor. The submission is supported by data from two global [Phase 3 studies](http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Finvestors.vrtx.com%2Freleasedetail.cfm%3FReleaseID%3D1019156&esheet=51673702&newsitemid=20170824005862&lan=en-US&anchor=Phase+3+studies&index=2&md5=9a863afef6ba8c7c02faaa475075c277&ref=fdaweb.com). The agency has set a user fee review target date of 2/28/2018.