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Drug

Galsulfase

Approved · EMA
Late-stage development
Also known as Arylsulfatase B galsulfase, Naglazyme, rhASB, Galsulfasa+2 more

Arylsulfatase B galsulfase, Naglazyme, rhASB, Galsulfasa, N-acetylgalactosamine-4-sulfatase, recombinant human, Recombinant N-acetylgalactosamine-4-sulfatase.

RxNorm578033UNII59UA429E5G
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Galsulfase
Aliases & brands
Arylsulfatase B galsulfaseNaglazymerhASBGalsulfasaN-acetylgalactosamine-4-sulfatase, recombinant humanRecombinant N-acetylgalactosamine-4-sulfatase
RxNorm CUI
578033
UNII
59UA429E5G
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2006-01-23
Latest approval
2006-01-23
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2006-01-23Approval
Approval: Naglazyme (EMA)
Indication: Naglazyme is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine-4-sulfatase… Show full indication

Naglazyme is indicated for long-term enzyme-replacement therapy in patients with a confirmed diagnosis of mucopolysaccharidosis VI (MPS VI; N-acetylgalactosamine-4-sulfatase deficiency; Maroteaux-Lamy syndrome) (see section 5.1). As for all lysosomal genetic disorders, it is of primary importance, especially in severe forms, to initiate treatment as early as possible, before appearance of non-reversible clinical manifestations of the disease. A key issue is to treat young patients aged <5 years suffering from a severe form of the disease, even though patients <5 years were not included in the pivotal phase-3 study.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

1 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
1
registered trials across all phases
LATEST COMPLETION 2009
1
Late-stage (III+)
1
Completed
PHASE DISTRIBUTIONn = 1
Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase 4 Multi-center, Multi-national, Open-label, Randomized, Two Dose Level Study of Naglazyme(TM) (Galsulfase) in Infants With Maroteaux-Lamy Syndrome (MPS VI)

CompletedPH IVBioMarin Pharmaceuticaln=42009

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 4 Multi-center, Multi-national, Open-label, Randomized, Two Dose Level Study of Naglazyme(TM) (Galsulfase) in Infants With Maroteaux-Lamy Syndrome (MPS VI)

CompletedPH IVBioMarin Pharmaceuticaln=42009
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.