FOLD - EC approves Amicus Therapeutics' Galafold for adolescents with Fabry disease

Amicus Therapeutics (NASDAQ:FOLD) perks up 3.6% premarket after announcing that the European Commission (EC) has approved Galafold (migalastat) for use in adolescents aged 12 to <16 years weighing ? 45 kg with a confirmed diagnosis of Fabry disease and who have an amenable mutation. Galafold is already approved in multiple geographies around the world, including the U.S., EU, and Japan, for adults who have an amenable variant, or mutation. The extension of the indication was supported by 1-month interim safety and pharmacokinetics data from Study AT1001-020 evaluating migalastat for the treatment of pediatric subjects aged 12 to <18 years with Fabry disease and with amenable mutations to the gene encoding ?-galactosidase A. Amicus will work closely with all relevant government authorities to secure access for eligible patients as quickly as possible.

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EC approves Amicus Therapeutics' Galafold for adolescents with Fabry disease