Peguniglasidase-alfa - Protalix Biotherapeutics

Drug Profile

Peguniglasidase-alfa - Protalix Biotherapeutics

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

Latest Information Update: 16 Nov 2017

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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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Fabry's disease

Most Recent Events

  • 13 Nov 2017 Protalix Biotherapeutics receives positive opinion from the EMA for its Orphan Medicinal Product Application for peguniglasidase-alfa for Fabry's disease
  • 18 Oct 2017 Pegunigalsidase alfa licensed to Chiesi worldwide (excluding USA) for the treatment of Fabry's disease
  • 09 May 2017 Protalix Biotherapeutics plans the phase III BRIGHT trial for pegunigalsidase alfa (2 mg/kg, once monthly) in Fabry's disease (Treatment-experienced) in December 2017 (NCT03180840)
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