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Phase 3 Open-Label Switch Over Study to Assess Safety, Efficacy & PK of Pegunigalsidase Alfa (PRX-102) 2mg/kg IV Every 4 Weeks for 52 Weeks in Fabry Disease Patients Currently Treated With Enzyme Replacement Therapy Fabrazyme or Replagal

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Trial Profile

Phase 3 Open-Label Switch Over Study to Assess Safety, Efficacy & PK of Pegunigalsidase Alfa (PRX-102) 2mg/kg IV Every 4 Weeks for 52 Weeks in Fabry Disease Patients Currently Treated With Enzyme Replacement Therapy Fabrazyme or Replagal

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 18 Sep 2023

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At a glance

  • Drugs Pegunigalsidase alfa (Primary)
  • Indications Fabry's disease
  • Focus Adverse reactions; Registrational
  • Acronyms BRIGHT
  • Sponsors Protalix Biotherapeutics

    • Most Recent Events

    • 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.
    • 24 Feb 2023 According to a Chiesi media release, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending marketing authorization for PRX-102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease, based on data from Phase 3 BALANCE, BRIDGE, and BRIGHT clinical trials, the Phase 1/2 clinical trial, and ongoing related extension studies. A final EC decision on the MAA is expected in the beginning of May 2023.
    • 15 Feb 2023 According to a Chiesi Global Rare Diseases media release, data will be presented at the 19th Annual WORLDSymposium.
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