Decision: Favourable

Decisions Table

Study Title:

A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation

  • NREC Code:

    21-NREC-CT-100

  • Decision:

    Favourable

  • Meeting Date:

    06/10/2021

  • Study Type:

    CT application

  • Principal Investigator:

    Prof. Edward McKone

  • PI Institution:

    St Vincent's University Hospital

  • Sponsor:

    Vertex Pharmaceuticals

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