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Pegunigalsidase alfa

Aliases
pegunigalsidase alfa, PRX-102
Name
ELFABRIO
INN Name
pegunigalsidase alfa
FDA Approved
Yes

3 clinical trials

1 organization

1 indication

1 document

Indication
Fabry Disease
Clinical trial
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, Estimated PCD: 2020-08-01
Clinical trial
Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) in Patients With Fabry Disease
Status: Active (not recruiting), Estimated PCD: 2025-01-01
Clinical trial
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 (not recruiting), Estimated PCD: 2024-09-01
Document
DailyMed Label: ELFABRIO
Organization
Chiesi USA, Inc.