Trial Profile
Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) in Patients With Fabry Disease
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 14 Feb 2024
Price :
$35
*
At a glance
- Drugs Pegunigalsidase alfa (Primary)
- Indications Fabry's disease
- Focus Adverse reactions; Registrational
- Sponsors Chiesi; Protalix Biotherapeutics
- 11 Feb 2024 This trial has been completed in Finland, according to European Clinical Trials Database record.
- 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 Dec 2026 to 1 Apr 2025.