Agalsidase beta

(Fabrazyme®)

Fabrazyme®

Drug updated on 11/4/2024

Dosage FormInjection (intravenous; 5 mg, 35mg)
Drug ClassHydrolytic lysozomal neutral glycosphingolipid-specific enzymes
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adult and pediatric patients 2 years of age and older with confirmed Fabry disease.

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Summary
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  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Agalsidase beta as an enzyme replacement therapy (ERT) for Fabry disease facilitates cellular globotriaosylceramide (Gb3) clearance, contributing to reducing the disease burden associated with Fabry disease symptoms.
  • The presence of neutralizing anti-drug antibodies (ADAs) in ERT-treated males may reduce the effectiveness of agalsidase beta, potentially leading to disease progression in this subgroup.
  • Comparative data between agalsidase beta and agalsidase alpha indicate both therapies aid in Gb3 clearance; however, specific comparative effectiveness outcomes were not detailed in the studies.
  • Agalsidase beta therapy is associated with infusion-associated reactions, though specific details of these reactions are not provided.
  • The formation of neutralizing anti-drug antibodies (ADAs) in males treated with enzyme replacement therapy for Fabry disease is noted as a safety concern, as it may reduce the therapy's effectiveness and potentially lead to disease progression.

Product Monograph / Prescribing Information

Document TitleYearSource
Fabrazyme (agalsidase beta) Prescribing Information.2024Sanofi-Aventis U.S. LLC., Bridgewater, NJ

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines