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# Vertex Gains Approval for Cystic Fibrosis Drug
- URL: https://www.fdaweb.com/vertex-gains-approval-for-cystic-fibrosis-drug/
- Published: 2018-02-12T12:00:00.000Z
- Updated: 2026-09-14T23:21:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140739

FDA has approved a [Vertex Pharmaceuticals NDA ](http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.vrtx.com&esheet=51757380&newsitemid=20180212006334&lan=en-US&anchor=Vertex+Pharmaceuticals+Incorporated&index=1&md5=3fb238fed11c4296d84fbb0874e0a195&ref=fdaweb.com)for Symdeko (tezacaftor/ivacaftor) for treating the underlying cause of cystic fibrosis in patients aged 12 and older who have two copies of the *F508del* mutation in the cystic fibrosis transmembrane conductance regulator gene or who have at least one mutation that is responsive to tezacaftor/ivacaftor. Approval was based on data from two Phase 3 studies called EVOLVE and EXPAND that enrolled about 750 people with cystic fibrosis. Across both studies, patients treated with Symdeko experienced statistically significant and clinically meaningful improvements in lung function and other measures of disease, with a favorable safety profile, the company says. The most common adverse events, regardless of treatment group, included infective pulmonary exacerbation and cough.