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 17h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NAGLAZYME (galsulfase) is a recombinant lysosomal enzyme replacement therapy designed to treat mucopolysaccharidosis VI (MPS VI), a rare genetic disorder. It works by replacing deficient arylsulfatase B enzyme, enabling the breakdown of glycosaminoglycans that accumulate in cells. The drug addresses a severe lysosomal storage disorder with limited treatment alternatives.
$6MPart D
LOE ApproachingStable
Product approaching loss of exclusivity with modest spending (~$6M) and low claims volume (52), signaling a consolidating franchise requiring defensive commercial strategy and operational efficiency focus.
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 positions professionals in a specialized rare disease ecosystem with deep relationships in a small, defined patient community and focus on operational excellence and provider retention. Career growth depends on strategic positioning within BioMarin's broader rare disease portfolio and potential involvement in biosimilar defense or pipeline transitions.
Worked on NAGLAZYME at BioMarin Pharmaceutical? 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.