Pegunigalsidase alfa - Chiesi/Protalix Biotherapeutics

Drug Profile

Pegunigalsidase alfa - Chiesi/Protalix Biotherapeutics

Alternative Names: Alpha-galactosidase; CHF 6657; Modified recombinant human alpha-GAL-A protein; Pegunigalsidase alfa; PRX-102; Recombinant human alpha galactosidase-A

Latest Information Update: 06 Jun 2018

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At a glance

  • Originator Protalix Biotherapeutics
  • Developer Protalix BioTherapeutics
  • Class Carminatives; Enzymes; Galactosidases; Recombinant proteins
  • Mechanism of Action Alpha-galactosidase replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Fabry's disease
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Fabry's disease

Most Recent Events

  • 03 Aug 2018 Protalix plans a phase III trial for Fabry's Disease in USA, Belgium, Norway and United Kingdom in November 2018 (NCT03614234)
  • 21 Jun 2018 Protalix Biotherapeutics plans a phase III extension trial in Fabry's disease in USA, Australia, Canada, Czech Republic, Hungary, Netherlands, Norway (IV) (NCT03566017)
  • 25 May 2018 Immunogenicity, pharmacodynamics and adverse events data from a phase III BALANCE study in Fabry disease presented at 55th European Renal Association – European Dialysis and Transplant Association
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