24 August 2017 - FDA grants priority review of the application and sets action date of 28 February 2018.

Vertex Pharmaceuticals today announced the acceptance of its applications for the use of the tezacaftor/ivacaftor combination treatment 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 by the U.S. FDA and the EMA. 

In the United States, the FDA has granted priority review of the new drug application and set an action date of 28 February 2018. The submissions are supported by positive results from two global Phase 3 studies.

Read Vertex Pharmaceuticals press release