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Fabagal® (Agalsidase beta)
Agalsidase beta is a recombinant human enzyme that replaces deficient α-galactosidase A, breaking down accumulated globotriaosylceramide (Gb3) in cells.
Agalsidase beta is a recombinant human enzyme that replaces deficient α-galactosidase A, breaking down accumulated globotriaosylceramide (Gb3) in cells. Used for Fabry disease (α-galactosidase A deficiency).
At a glance
| Generic name | Fabagal® (Agalsidase beta) |
|---|---|
| Sponsor | ISU Abxis Co., Ltd. |
| Drug class | Enzyme replacement therapy (ERT) |
| Target | α-galactosidase A (GLA enzyme) |
| Modality | Biologic |
| Therapeutic area | Rare genetic disease / Lysosomal storage disorder |
| Phase | Phase 3 |
Mechanism of action
Fabry disease is caused by mutations in the GLA gene, leading to deficiency of the lysosomal enzyme α-galactosidase A. This deficiency causes pathological accumulation of Gb3 in multiple tissues including the heart, kidneys, and nervous system. Agalsidase beta is a recombinant replacement enzyme that catalyzes the degradation of Gb3, reducing tissue burden and slowing disease progression.
Approved indications
- Fabry disease (α-galactosidase A deficiency)
Common side effects
- Infusion-related reactions
- Fever
- Chills
- Headache
- Nausea
Key clinical trials
- Efficacy and Safety of Enzyme Replacement Therapy in Patients With Fabry Disease
- Evaluate the Safety and Efficacy of Fabagal® (Agalsidase Beta) in Patients With Fabry Disease (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Fabagal® (Agalsidase beta) CI brief — competitive landscape report
- Fabagal® (Agalsidase beta) updates RSS · CI watch RSS
- ISU Abxis Co., Ltd. portfolio CI