Peguniglasidase-alfa - Protalix Biotherapeutics

Drug Profile

Peguniglasidase-alfa - Protalix Biotherapeutics

Alternative Names: Alpha-galactosidase; Pegunigalsidase alfa; PRX-102; Recombinant human alpha galactosidase-A

Latest Information Update: 17 Jan 2017

Price : $50

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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Fabry's disease

Most Recent Events

  • 09 Jan 2017 Protalix plans a phase III trial for Fabry's disease (Treatment experienced) in Australia, Cananda, Czech republic, Germany, Netherlands, Norway, Spain and United Kingdom (IV, Infusion) (NCT03018730)
  • 29 Sep 2016 Protalix withdrew the phase III BRIGHT trial, prior to enrolment, in Fabry's disease (In adolescents, In adults, Treatment-naive) in USA due to non-feasibility of the protocol (IV) (NCT02921620)
  • 10 Aug 2016 Additional efficacy and adverse events data from a phase I/II trial in Fabry's disease released by Protalix BioTherapeutics
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