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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

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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: 13 Dec 2024

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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

    • 09 Dec 2024 According to a Chiesi media release, today announced based on clinical trial data from this trial and its extension trial, European Medicines Agency (EMA) has validated the Variation Submission for pegunigalsidase alfa to label a less frequent dosing regimen at a dose of 2 mg/kg body weight administered every four weeks in adult patients with Fabry disease. The currently approved dose of pegunigalsidase alfa is 1 mg/kg administered every two weeks.
    • 08 Oct 2024 Planned End Date changed from 1 Dec 2024 to 28 Mar 2026.
    • 08 Oct 2024 Planned primary completion date changed from 1 Sep 2024 to 31 Dec 2025.

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