Agalsidase beta

Drug Profile

Agalsidase beta

Alternative Names: Alpha-galactosidase - Genzyme; Fabrazyme; recombinant human α-galactosidase A

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

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

  • Marketed Fabry's disease

Most Recent Events

  • 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)
  • 08 Apr 2011 Genzyme Corporation has been acquired by sanofi-aventis
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