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A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

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Trial Profile

A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Ivacaftor/lumacaftor (Primary)
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Sponsors Vertex Pharmaceuticals

Most Recent Events

  • 10 Jan 2018 According to a Vertex Pharmaceuticals media release, based on the data from this and another phase III trial, the European Commission has granted extension of the Marketing Authorization for ORKAMBI (lumacaftor/ivacaftor), to treat the underlying cause of cystic fibrosis (CF) in people with two copies of the F508del mutation, to include children ages 6 through 11.
  • 10 Nov 2017 According to a Vertex Pharmaceuticals media release, European Union Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending extension of the Marketing Authorization for ORKAMBI (lumacafator/ivacaftor) to children with cystic fibrosis (CF) ages 6 through 11 who have two copies of the F508del mutation.
  • 03 Nov 2017 According to a Vertex Pharmaceuticals media release, data were presented at the Annual North American Cystic Fibrosis Conference (NACFC).

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