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Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Administered by Intravenous Infusion Every 4 Weeks in Adult Patients With Fabry Disease

Trial Profile

Open Label Extension Study to Evaluate the Long-term Safety and Efficacy of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Administered by Intravenous Infusion Every 4 Weeks in Adult Patients With Fabry Disease

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Sep 2023

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At a glance

  • Drugs Pegunigalsidase alfa (Primary)
  • Indications Fabry's disease
  • Focus Adverse reactions; Registrational
  • Acronyms Bright 51
  • Sponsors Chiesi; Protalix Biotherapeutics
  • Most Recent Events

    • 11 Sep 2023 Planned number of patients changed from 40 to 28.
    • 05 May 2023 According to a Chiesi media release, the European Commission (EC) has granted marketing authorization to PRX-102 (pegunigalsidase alfa) in the European Union (EU) for the treatment of adult patients with Fabry disease.
    • 28 Mar 2023 Planned End Date changed from 1 Oct 2024 to 1 Dec 2024.
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