Agalsidase beta

Drug Profile

Agalsidase beta

Alternative Names: Fabrazyme; Recombinant human α-galactosidase A - Sanofi Genzyme

Latest Information Update: 10 Sep 2017

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At a glance

  • Originator Genzyme Canada; Genzyme Corporation
  • Developer Genzyme Canada; Icahn School of Medicine at Mount Sinai; Sanofi Genzyme
  • Class Galactosidases; Glycoproteins; Isoenzymes
  • 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

  • Marketed Fabry's disease

Most Recent Events

  • 17 Aug 2017 Discontinued - Phase-III for Fabry's disease (Early-stage disease, In adolescents, In children, Treatment-naive) in Norway, Netherlands, Canada, Brazil, Argentina, Poland, United Kingdom, Czech Republic, France and USA (IV), because not listed on Sanofi Genzyme pipeline, August 2017
  • 03 Mar 2015 Launched for Fabry's disease in Brazil, Chile, Argentina, Mexico, Malaysia, Turkey, Russia, Switzerland, Hong Kong and India (IV) prior to March 2015
  • 04 Dec 2014 Genzyme completes enrolment in the phase IIIb FILED trial for Fabry's disease (Early-stage disease, In adolescents, In children, Treatment-naive) in USA, Canada, Argentina, Brazil, United Kingdom, Netherlands, Poland, France, Czech Republic and Norway (NCT00701415)
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