A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

Trial Profile

A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2017

At a glance

  • Drugs Ivacaftor/tezacaftor (Primary) ; Ivacaftor
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Acronyms EVOLVE
  • Sponsors Vertex Pharmaceuticals
  • Most Recent Events

    • 24 Aug 2017 According to a Vertex media release, the U.S. FDA and the EMA have accepted to review the marketing applications for the use of tezacaftor/ivacaftor combination treatment in people with cystic fibrosis (CF) 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. In the US, the FDA has granted Priority Review of the New Drug Application (NDA) and set an action date of February 28, 2018.
    • 10 Jun 2017 Biomarkers information updated
    • 28 Mar 2017 According to a Vertex Pharmaceuticals media release, based on results of this and other (CTP 25318) trial, company plans to submit a NDA to the U.S. FDA and a MAA to the European Medicines Agency (EMA) in the third quarter of 2017 for the tezacaftor/ivacaftor combination treatment in people with CF ages 12 and older who have two copies of the F508del mutation and in people who have one mutation that results in residual CFTR function.
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