- The European Commission has approved Amicus Therapeutics Inc (NASDAQ: FOLD) Galafold (migalastat) for use in adolescents with Fabry disease who have an amenable mutation.
- Galafold is already approved in 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 evaluated the safety, pharmacokinetics, pharmacodynamics, and efficacy of migalastat treatment in pediatric subjects aged 12 to less than 18 years.
- Galafold is not approved for adolescents outside of Europe.
- Price Action: FOLD shares are up 1.72% at $9.45 during the premarket session on the last check Monday.
- Related content: Benzinga’s Full FDA Calendar.
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