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: 14 Sep 2023
Price :
$35
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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
- 11 Sep 2023 Planned number of patients changed from 40 to 28.
- 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 Oct 2024 to 1 Dec 2024.