Amicus Therapeutics Receives Marketing Authorization for Galafold® (migalastat) for Fabry Disease in Argentina
Amicus Therapeutics, Inc. (FOLD)
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Source: GlobeNewswire
First Oral Precision Medicine Approved for People Living with Fabry Disease with an Amenable Mutation in Argentina First Amicus Regulatory Approval in Latin America CRANBURY, N.J., and BUENOS AIRES, Argentina, Aug. 02, 2019 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the Agency of Medicines, Food and Medical Devices (ANMAT) in Argentina has granted approval for the first-in-class, oral small molecule pharmacological chaperone Galafold® (migalastat), as a monotherapy for the treatment of people aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation. Galafold® is the first and only oral precision medicine for Fabry disease approved in Argentina. Amicus is working with a local partner, Pint Pharma, to complete the requirements to launch Galafold® in the coming months. Argentina represents the first approval for Galafold® in Latin America. Additional submissions
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