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A Randomized, Placebo-Controlled, Blind-Start, Single-Crossover Phase 3 Study to Assess the Efficacy and Safety of UX003 rhGUS Enzyme Replacement Therapy in Patients With MPS 7

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Trial Profile

A Randomized, Placebo-Controlled, Blind-Start, Single-Crossover Phase 3 Study to Assess the Efficacy and Safety of UX003 rhGUS Enzyme Replacement Therapy in Patients With MPS 7

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Vestronidase alfa (Primary)
  • Indications Mucopolysaccharidosis VII
  • Focus Registrational; Therapeutic Use
  • Sponsors Ultragenyx Pharmaceutical

    • Most Recent Events

    • 23 Nov 2018 Results published in the Clinical Pharmacokinetics
    • 27 Aug 2018 According to an Ultragenyx Pharmaceutical media release, the European Commission (EC) has approved the Marketing Authorization Application (MAA) for Mepsevii™ (vestronidase alfa), for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII (MPS VII; Sly syndrome). Mepsevii is now approved for use in all 28 EU countries and in Iceland, Liechtenstein and Norway.
    • 29 Jun 2018 According to an Ultragenyx Pharmaceutical media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization under exceptional circumstances of Mepsevii (vestronidase alfa) for the treatment of non-neurological manifestations of Mucopolysaccharidosis VII and the EC decision is expected in the third quarter of 2018.

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