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
Phase of Trial: Phase III
Latest Information Update: 12 Feb 2018
At a glance
- Drugs Migalastat (Primary) ; Enzyme replacements
- Indications Fabry's disease
- Focus Registrational; Therapeutic Use
- Acronyms ATTRACT
- Sponsors Amicus Therapeutics
- 12 Feb 2018 According to an Amicus Therapeutics media release, based on the data from FACETS and ATTRACT studies, the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing under priority review for the oral migalastat HCl for the treatment of patients 16 years and older with Fabry disease who have amenable mutations. The Prescription Drug User Fee Act (PDUFA) goal date for the FDA decision is August 13, 2018.
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History