BLAINJECTIONINJECTABLEPriority Review
Approved
May 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
Priority Review
NAGLAZYME (galsulfase) by BioMarin Pharmaceutical. Approved for hydrolytic lysosomal glycosaminoglycan-specific enzyme [epc]. First approved in 2005.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NAGLAZYME (galsulfase) is a recombinant hydrolytic enzyme indicated for mucopolysaccharidosis VI (MPS VI), a rare lysosomal storage disorder. It works by replacing deficient arylsulfatase B, enabling breakdown of accumulated glycosaminoglycans in lysosomes. The drug is administered intravenously as enzyme replacement therapy (ERT).
$6.0MPart D
LOE ApproachingProduct is in late-stage lifecycle with modest claims volume (52 in 2023), signaling a small, specialized team focused on rare disease maintenance and patient retention.
Mechanism of Action
Pharmacologic Class:
Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Naglazyme After Allo Transplant for Maroteaux-Lamy Syndrome
Started Jan 2016
1 enrolled
Maroteaux-Lamy Syndrome
A Phase 4 Two Dose Level Study of Naglazyme(TM) (Galsulfase) in Infants With MPS VI
Started May 2006
4 enrolled
Mucopolysaccharidosis VIMaroteaux-Lamy Syndrome
Career Relevance
NAGLAZYME represents a stable, niche rare-disease franchise within BioMarin's portfolio. Careers on this product center on specialized market access, patient support programs, and rare disease expertise rather than high-growth commercial expansion.
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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.