Naglazyme
Naglazyme ingredients
| Active ingredient | Strength |
|---|---|
| Galsulfase | 5 mg/5mL |
What Naglazyme is used for
The FDA lists the approved uses on the official label (below). In the EU, galsulfase is approved as Naglazyme for:
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.
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Naglazyme
- Generic name
- Galsulfase
- Made by
- BioMarin Pharmaceutical Inc.
- Forms
- Solution
- Given
- Intravenous
- Drug class
- Hydrolytic Lysosomal Glycosaminoglycan-specific Enzyme
- FDA approval
- Biologic licence (BLA) BLA125117
- On the US market since
- 2005
Official information
- Naglazyme prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Galsulfase)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Naglazyme?
Naglazyme (Galsulfase) is a specialist medicine made by BioMarin Pharmaceutical Inc., approved by the US FDA.
What are the ingredients of Naglazyme?
Naglazyme contains Galsulfase (5 mg/5mL).
Is Naglazyme approved in Europe?
The same active substance is approved in the EU as Naglazyme.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA