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α-Galactosidase

Generic Name
α-Galactosidase
Brand Names
Fabrazyme
Drug Type
Biotech
Unique Ingredient Identifier
RZD65TSM9U

Overview

Agalsidase beta is a recombinant human α-galactosidase A similar to agalsidase alfa. While patients generally do not experience a clinically significant difference in outcomes between the two drugs, some patients may experience greater benefit with agalsidase beta. Use of agalsidase beta has decreased in Europe, in favor of agalsidase alfa, after a contamination event in 2009. Agalsidase beta was granted FDA approval on 24 April 2003.

Background

Agalsidase beta is a recombinant human α-galactosidase A similar to agalsidase alfa. While patients generally do not experience a clinically significant difference in outcomes between the two drugs, some patients may experience greater benefit with agalsidase beta. Use of agalsidase beta has decreased in Europe, in favor of agalsidase alfa, after a contamination event in 2009. Agalsidase beta was granted FDA approval on 24 April 2003.

Indication

Agalsidase beta is indicated in the treatment of Fabry disease.

Associated Conditions

  • Fabry's Disease

FDA Approved Products

Fabrazyme
Manufacturer:Genzyme Corporation
Route:INTRAVENOUS
Strength:5 mg in 1 mL
Approved: 2024/02/23
NDC:58468-0041
Fabrazyme
Manufacturer:Genzyme Corporation
Route:INTRAVENOUS
Strength:5 mg in 1 mL
Approved: 2024/02/23
NDC:58468-0040

Singapore Approved Products

Fabrazyme ® 35mg (agalsidase beta)
Manufacturer:Genzyme Corporation, Genzyme Ireland Limited
Form:INJECTION, POWDER, FOR SOLUTION
Strength:37.0mg/35mg vial
Online:Yes
Approved: 2009/03/10
Approval:SIN13609P
Fabrazyme ® 5mg (agalsidase beta)
Manufacturer:Genzyme Corporation, Genzyme Ireland Limited (Fill-finish)
Form:INJECTION, POWDER, FOR SOLUTION
Strength:5.5mg/5mg vial
Online:Yes
Approved: 2009/03/10
Approval:SIN13610P

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