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 Dec 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 Dec 2017 According to an Amicus Therapeutics media release, the company has submitted a new drug application (NDA) to the US FDA to request approval of the oral precision medicine migalastat HCl (migalastat) for the treatment of patients 16 years and older with Fabry disease who have amenable mutations. The regulatory applications were based on data from the FACETS and ATTRACT trials.
    • 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.
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