Phase III results with Galafold (migalastat) in Fabry Disease published in New England Journal of Medicine- Amicus Therapeutics
Amicus Therapeutics announced that data from the pivotal Phase III Study 011 (FACETS) evaluating the efficacy and safety of the oral pharmacological chaperone Galafold (migalastat) in individuals with Fabry disease were published in the August 11 issue of the New England Journal of Medicine (NEJM). This Phase III study, together with the Phase III ERT-switch Study 012, supported the European Commission�s recent full approval for migalastat in the European Union as a first line therapy for Fabry disease in patients 16 years and older who have an amenable genetic mutation.
See: "Treatment of Fabry�s Disease with the Pharmacologic Chaperone Migalastat" Dominique P. Germain et al. N Engl J Med 2016; 375:545-555 August 11, 2016 DOI: 10.1056/NEJMoa1510198
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