The Galafold Full Prescribing Information includes a list of GLA variants that have been identified as amenable to Galafold.
For answers to questions about amenability, you can also contact Amicus Medical Information at
1-877-4-AMICUS or MedInfoUSA@amicusrx.com.
Galafold® (migalastat) is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene (GLA) variant based on in vitro assay data.
This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
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This form serves a dual purpose:
as a prescription for Galafold and as a way for patients to register for AMICUS ASSIST®.