Trial Profile
An Open Label Study of the Safety and Efficacy of PRX-102 in Patients With Fabry Disease Currently Treated With REPLAGAL (Agalsidase Alfa)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 18 Sep 2023
Price :
$35
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At a glance
- Drugs Pegunigalsidase alfa (Primary)
- Indications Fabry's disease
- Focus Adverse reactions; Registrational
- Acronyms BRIDGE
- Sponsors Protalix Biotherapeutics
- 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.
- 24 Feb 2023 According to a Chiesi media release, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending marketing authorization for PRX-102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease, based on data from Phase 3 BALANCE, BRIDGE, and BRIGHT clinical trials, the Phase 1/2 clinical trial, and ongoing related extension studies. A final EC decision on the MAA is expected in the beginning of May 2023.
- 05 Dec 2022 According to a Chiesi media release, the U.S. Food and Drug Administration (FDA) has accepted the resubmitted Biologics License Application (BLA) for pegunigalsidase alfa (PRX-102) for the proposed treatment of adult patients with Fabry disease; The FDA indicated in the BLA filing communication letter that the resubmitted BLA was considered a complete, class 2 response and set an action date of May 9, 2023, under the Prescription Drug User Fee Act (PDUFA).