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A Randomized, Double Blind, Active Control Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function in Patients With Fabry Disease Previously Treated With Agalsidase Beta

Trial Profile

A Randomized, Double Blind, Active Control Study of the Safety and Efficacy of PRX-102 Compared to Agalsidase Beta on Renal Function in Patients With Fabry Disease Previously Treated With Agalsidase Beta

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 Jan 2024

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At a glance

  • Drugs Pegunigalsidase alfa (Primary) ; Agalsidase beta
  • Indications Fabry's disease
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms BALANCE
  • Sponsors Protalix Biotherapeutics

Most Recent Events

  • 10 Jan 2024 Results presented in a Chiesi media release.
  • 10 Jan 2024 According to a Chiesi media release, the results are published in the peer-reviewed Journal of Medical Genetics.
  • 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.

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