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
Phase of Trial: Phase III
Latest Information Update: 15 May 2017
At a glance
- Drugs Ivacaftor/tezacaftor (Primary) ; Ivacaftor
- Indications Cystic fibrosis
- Focus Registrational; Therapeutic Use
- Acronyms EVOLVE
- Sponsors Vertex Pharmaceuticals
- 07 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.
- 28 Mar 2017 Results published in a Vertex Pharmaceuticals media release.