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Agalsidase beta - Sanofi

Drug Profile

Agalsidase beta - Sanofi

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

Latest Information Update: 05 Nov 2023

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At a glance

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

Highest Development Phases

  • Marketed Fabry's disease

Most Recent Events

  • 31 Dec 2022 Sanofi has patent protection for pediatric indication with confirmed Fabry's disease, in USA, prior to December 2022
  • 01 Oct 2021 Launched for Fabry's disease in China (IV), before October 2021 (NCT05054387) (NDR Batch 21)
  • 12 Mar 2021 Efficacy data from a phase IV trial in Fabry's disease released by Sanofi Genzyme
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