An Extension of Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks for 38 Weeks to Adult Fabry Patients
Latest Information Update: 24 Nov 2022
At a glance
- Drugs Pegunigalsidase alfa (Primary)
- Indications Fabry's disease
- Focus Adverse reactions
- Sponsors Protalix Biotherapeutics
- 14 Nov 2022 According to a Protalix BioTherapeutics media release, the company has resubmitted the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for PRX-102 (pegunigalsidase alfa) for the treatment of adult patients with Fabry disease on November 9, 2022 based on the data from several trials including this. Protalix and Chiesi anticipate that the FDA will complete its review of the resubmission within six months of receipt.
- 09 Jan 2018 Status changed from recruiting to completed.
- 03 Jan 2018 Argentina, Chile, Germany, Israel and Serbia were the planned locations as per results published in European Clinical Trials Database record.