Amicus's Fabry Disease Medicine Gets European Approval For Use In Adolescents

by Vandana Singh, Benzinga Editor

August 2, 2021 8:50 AM | 1 min read | Make a Comment

The European Commission has approved Amicus Therapeutics Inc 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.