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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; Pegunigalsidase-alfa-Protalix-Biotherapeutics; PRX-102; Recombinant human alpha galactosidase-A-Protalix; Recombinant-alpha-galactosidase-Protalix

Latest Information Update: 18 Nov 2019

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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

  • 18 Nov 2019 9279200: No updates, info already updated
  • 17 Oct 2019 Updated efficacy data from the phase III BRIDGE trial in Fabry's disease released by Protalix BioTherapeutics
  • 24 Sep 2019 Protalix BioTherapeutics completes enrolment in the phase III BALANCE trial for Fabry disease in US, Australia, Argentina, Belgium, Brazil, Canada, the Czech Republic, Germany, Hungary, Italy, Netherlands, Noway, Slovenia, Spain, Switzerland, Turkey and the UK (NCT02795676)
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