Naglazyme
What Naglazyme is used 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.
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Naglazyme
- Active substance
- galsulfase
- Disease area
- Mucopolysaccharidosis VI
- Medicine group
- Other alimentary tract and metabolism products
- ATC code
- A16AB
- Marketing authorisation holder
- BioMarin International Limited
- Authorised in the EU since
- 2006
Official information
In the USA
Same active substance: Naglazyme
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 used 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 …
What is the active substance in Naglazyme?
Naglazyme contains galsulfase.
Who makes Naglazyme?
The EU marketing authorisation holder is BioMarin International Limited.
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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