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.
Indication
Agalsidase beta is indicated in the treatment of Fabry disease.
Associated Conditions
- Fabry's Disease
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/01/26 | N/A | Recruiting | |||
2021/09/23 | Phase 4 | Completed | Genzyme, a Sanofi Company | ||
2006/04/11 | Phase 4 | Withdrawn | Genzyme, a Sanofi Company | ||
2005/10/03 | Phase 4 | Terminated | Genzyme, a Sanofi Company | ||
2005/09/01 | Phase 4 | Completed | Genzyme, a Sanofi Company | ||
2003/12/25 | Phase 3 | Completed | Genzyme, a Sanofi Company |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Genzyme Corporation | 58468-0041 | INTRAVENOUS | 5 mg in 1 mL | 2/23/2024 | |
| Genzyme Corporation | 58468-0040 | INTRAVENOUS | 5 mg in 1 mL | 2/23/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/3/2001 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Fabrazyme ® 35mg (agalsidase beta) | SIN13609P | INJECTION, POWDER, FOR SOLUTION | 37.0mg/35mg vial | 3/10/2009 | |
| Fabrazyme ® 5mg (agalsidase beta) | SIN13610P | INJECTION, POWDER, FOR SOLUTION | 5.5mg/5mg vial | 3/10/2009 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FABRAZYME agalsidase beta-rch 35mg powder for injection vial | 82755 | Medicine | A | 5/30/2002 | |
| FABRAZYME agalsidase beta - rch 5.5mg powder for injection vial | 94000 | Medicine | A | 4/14/2003 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| FABRAZYME 5 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION | 01188004 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized | |
| FABRAZYME 35 MG POLVO PARA CONCENTRADO PARA SOLUCION PARA PERFUSION | 01188001 | POLVO PARA CONCENTRADO PARA SOLUCIÓN PARA PERFUSIÓN | Uso Hospitalario | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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