Amicus Therapeutics has commenced the commercial launch of the precision medicine Galafold in Spain following final pricing and reimbursement decisions. Galafold is now reimbursed in Spain for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation. Fabry disease is a genetic disease which causes deficiency of an enzyme called alpha-galactosidase A (alpha-Gal A), which is the result of mutations in the GLA gene. As a precision medicine, Galafold is designed to restore alpha-Gal A activity in patients who have amenable mutations (an estimated 35% to 50% of the Fabry population). The European Commission granted the first approval for Galafold for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease and who have an amenable mutation. Outside the EU, migalastat is approved in Switzerland, Israel, Australia, Canada and South Korea, with regulatory submissions under review in additional geographies.