BLAINTRAVENOUSVIALPriority Review
Approved
Apr 2003
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
19
Data completeness
5/8 — Partial
Priority Review
FABRAZYME (agalsidase beta) by Sanofi is (agalsidase beta) provides an exogenous source of α-galactosidase a in fabry disease patients. First approved in 2003.
Drug data last refreshed 1h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FABRAZYME (agalsidase beta) is an intravenous enzyme replacement therapy that provides an exogenous source of α-galactosidase A for patients with Fabry disease. The drug is internalized into lysosomes where it catalyzes the breakdown of accumulated GL-3 (globotriaosylceramide), addressing the root enzymatic deficiency. It represents the standard-of-care enzyme replacement approach for this rare X-linked lysosomal storage disorder.
$0.040BPart D
LOE ApproachingProduct is in mature lifecycle stage with modest commercial scale; commercial team focus shifting toward retention and lifecycle management as LOE approaches.
Mechanism of Action
(agalsidase beta) provides an exogenous source of α-galactosidase A in Fabry disease patients. Agalsidase beta is internalized and transported into lysosomes where it exerts enzymatic activity and reduces accumulated GL-3.
Pharmacologic Class:
Hydrolytic Lysosomal Neutral Glycosphingolipid-specific Enzyme
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (19)
A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme
Started Nov 2023
8 enrolled
Fabry's Disease
Agalsidase Beta Long-Term Treatment Outcome for Fabry Disease Patients With IVS4 Mutation in Taiwan
Started Sep 2023
78 enrolled
Fabry Disease
Evaluate the Safety and Efficacy of Fabagal® (Agalsidase Beta) in Patients With Fabry Disease
Started Apr 2023
24 enrolled
Fabry Disease
Switch Over Study of Biosimilar Agalsidase Beta for Fabry Disease
Started Dec 2022
20 enrolled
Fabry Disease
China Post-marketing Surveillance (PMS) Study of Fabrazyme®
Started Oct 2021
22 enrolled
Fabry Disease
Worked on FABRAZYME at Sanofi? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.