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: 08 Nov 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 No

Highest Development Phases

  • Phase III Fabry's disease

Most Recent Events

  • 07 Nov 2018 Protalix BioTherapeutics plans discussion with the US FDA regarding the most optimal regulatory pathway for pegunigalsidase alfa, in the 1H of 2019
  • 05 Oct 2018 Preliminary safety and efficacy data from the phase III BRIDGE trial in Fabry's disease released by Protalix BioTherapeutics
  • 21 Sep 2018 Preliminary efficacy data from a phase III BRIDGE trial Fabry's disease released by Protalix BioTherapeutics
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