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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/03/15 | Phase 3 | Active, not recruiting | |||
2021/07/23 | Phase 3 | Completed | |||
2021/04/12 | Phase 3 | Terminated | |||
2019/10/30 | Phase 4 | Withdrawn | |||
2007/06/18 | Phase 4 | UNKNOWN | |||
2006/07/27 | Phase 1 | Completed | |||
2004/12/01 | Phase 4 | Completed | |||
2004/06/07 | Phase 2 | Completed | |||
2004/01/07 | Phase 2 | Completed | |||
2003/11/04 | Phase 2 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/3/2001 | ||
Authorised | 8/3/2001 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| REPLAGAL CONCENTRATE FOR SOLUTION FOR INFUSION 1 MG/ML | SIN16197P | INFUSION, SOLUTION CONCENTRATE | 1.0 mg/mL | 5/17/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Agalsidase Alfa Concentrated Solution for Infusion | 国药准字SJ20200021 | 生物制品 | 注射剂 | 8/26/2020 |
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 |
|---|---|---|---|---|---|
| REPLAGAL agalsidase alfa ghu 3.5mg/3.5mL concentrated injection vial | 82818 | Medicine | A | 5/17/2002 |