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
Price :
$35
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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
- 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.