Benzinga | Aug 2, 2021 08:51AM EDT

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

* 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.