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 9h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NAGLAZYME (galsulfase) is a recombinant human arylsulfatase B enzyme replacement therapy administered by intravenous injection. It is indicated for mucopolysaccharidosis VI (MPS VI), a rare lysosomal storage disorder caused by deficiency of arylsulfatase B, leading to accumulation of glycosaminoglycans in tissues. The drug works by hydrolytically cleaving glycosaminoglycans to reduce pathological accumulation.
$6MPart D
LOE ApproachingStable
Product approaching loss of exclusivity with modest Part D spending reflects niche rare disease indication; commercial teams likely focused on retention and pipeline transition.
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
Working on NAGLAZYME positions you in the rare disease specialty pharma space with deep relationships in a highly specialized patient/physician community. However, the LOE timeline suggests career mobility may be needed within 2-3 years as commercial teams rightsize.
Brand Manager
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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.