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Phase 3, Open-Label, Single-Arm, Single-Dose Gene Replacement Therapy Clinical Trial for Patients With Spinal Muscular Atrophy Type 1 With One or Two SMN2 Copies Delivering AVXS-101 by Intravenous Infusion

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Trial Profile

Phase 3, Open-Label, Single-Arm, Single-Dose Gene Replacement Therapy Clinical Trial for Patients With Spinal Muscular Atrophy Type 1 With One or Two SMN2 Copies Delivering AVXS-101 by Intravenous Infusion

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 17 Aug 2022

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At a glance

  • Drugs Onasemnogene-abeparvovec (Primary)
  • Indications Spinal muscular atrophy
  • Focus Registrational; Therapeutic Use
  • Acronyms STR1VE-US; STRIVE
  • Sponsors AveXis; Novartis Gene Therapies

    • Most Recent Events

    • 13 Mar 2022 Results of post-hoc analysis from START, STR1VE-EU and STR1VE-US studies were presented at Novartis media release.
    • 01 Apr 2021 Results published in the Lancet Neurology
    • 16 Dec 2020 According to a Novartis Pharmaceuticals media release, Health Canada has approved Zolgensma (onasemnogene abeparvovec) for the treatment of pediatric patients with 5q spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene and 3 or fewer copies of SMN2 gene; or infantile-onset SMA1, based on data from completed and ongoing open-label, single-arm, clinical trials.

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