Extension Study of 1 mg/kg Pegunigalsidase Alfa in Patients With Fabry Disease

The objective of PB-102-F60 is to evaluate the long-term safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa administered intravenously every other week in adult Fabry patients who have successfully completed studies PB-102-F03, PB-102-F20 or PB-102-F30.

The objective of PB-102-F60 is to evaluate the long-term safety, tolerability, and efficacy parameters of 1 mg/kg pegunigalsidase alfa every other week in adult Fabry patients who have completed studies PB-102-F20, PB-102-F30 or completed at least 36 months in Study PB-102-F03). Patients will be enrolled to receive 1 mg/kg pegunigalsidase alfa as intravenous infusions every 2 weeks (±3 days). The duration of treatment will be no less than 24 months and up to 60 months or until pegunigalsidase alfa is commercially available to the patient at the discretion of the Sponsor. An interim analysis may be performed for administrative purposes during the conduct of the study. For the analysis, available efficacy and safety parameters will be summarized using descriptive statistics.