MedPath

Agalsidase alfa

Generic Name
Agalsidase alfa
Brand Names
Replagal
Drug Type
Biotech
Unique Ingredient Identifier
2HLC17MX9G

Overview

Agalsidase alfa is a recombinant human α-galactosidase A similar to agalsidase beta. 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 alfa was granted EMA approval on 3 August 2001.

Background

Agalsidase alfa is a recombinant human α-galactosidase A similar to agalsidase beta. 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 alfa was granted EMA approval on 3 August 2001.

Indication

Agalsidase alfa is indicated in the treatment of Fabry disease.

Associated Conditions

  • Fabry's Disease

FDA Approved Products

No FDA products found for this drug

Singapore Approved Products

REPLAGAL CONCENTRATE FOR SOLUTION FOR INFUSION 1 MG/ML
Manufacturer:Vetter Pharma-Fertigung GmbH & Co. KG (bulk production and primary packager), Cangene bioPharma LLC (bulk production and primary packager)
Form:INFUSION, SOLUTION CONCENTRATE
Strength:1.0 mg/mL
Online:Yes
Approved: 2021/05/17
Approval:SIN16197P

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