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A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)

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Trial Profile

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Jul 2024

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At a glance

  • Drugs Deutivacaftor (Primary) ; Deutivacaftor/tezacaftor/vanzacaftor (Primary) ; Tezacaftor (Primary) ; Vanzacaftor (Primary) ; Elexacaftor/ivacaftor/tezacaftor; Ivacaftor
  • Indications Cystic fibrosis
  • Focus Registrational; Therapeutic Use
  • Acronyms SKYLINE 102
  • Sponsors Vertex Pharmaceuticals
  • Most Recent Events

    • 02 Jul 2024 According to a Vertex Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for investigational once-daily vanzacaftor/tezacaftor/deutivacaftor triple combination therapy (vanza triple) for people living with cystic fibrosis (CF) ages 6 years and older, Vertex used a priority review voucher for this submission reducing the review time from 10 months to 6 months, resulting in a PDUFA target action date of January 2, 2025
    • 10 Mar 2024 This trial has been completed in Sweden (Global end date: 2023-11-21)according to European Clinical Trials Database record.
    • 29 Feb 2024 According to a Vertex Pharmaceuticals media release, In February 2024, Vertex Pharmaceuticals announced its intention to submit a New Drug Application (NDA) to the US FDA using a priority review voucher for the treatment of people with cystic fibrosis 6 years of age and older by mid-2024. The planned submission is based on the results from the phase III SKYLINE 102, SKYLINE 103 and pivotal RIDGELINE studies.
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