A RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF AT1001 AND ENZYME REPLACEMENT THERAPY (ERT) IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS, WHO WERE PREVIOUSLY TREATED WITH ERT

Trial Profile

A RANDOMIZED, OPEN-LABEL STUDY TO COMPARE THE EFFICACY AND SAFETY OF AT1001 AND ENZYME REPLACEMENT THERAPY (ERT) IN PATIENTS WITH FABRY DISEASE AND AT1001-RESPONSIVE GLA MUTATIONS, WHO WERE PREVIOUSLY TREATED WITH ERT

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Sep 2017

At a glance

  • Drugs Migalastat (Primary) ; Enzyme replacements
  • Indications Fabry's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms ATTRACT
  • Sponsors Amicus Therapeutics
  • Most Recent Events

    • 14 Sep 2017 According to an Amicus Therapeutics media release, based on the clinical data from two Phase 3 pivotal studies in both treatment naive (FACETS) and enzyme replacement therapy switch patients (ATTRACT), as well as an ongoing long-term extension study and overall body of evidence, Health Canada has approved the oral precision medicine Galafold for long-term treatment of adults with a confirmed diagnosis of Fabry disease and who have an alpha-GalA mutation.
    • 25 Aug 2017 According to an Amicus Therapeutics media release, data will be presented at the 13th International Congress of Inborn Errors of Metabolism 2017.
    • 15 Aug 2017 According to an Amicus Therapeutics media release, the Australian Therapeutic Goods Administration (TGA) has approved Galafold (migalastat) for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation, based on data from FACETS, ATTRACT and extension study [700247672].
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