Therapeutic Galsulfase enzyme from the original Naglazyme® commercial drug.

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Naglazyme® - Galsulfase Reference Drug

Drug nameNaglazyme®
API typeGalsulfase is a recombinant form of human N-acetylgalactosamine 4-sulfatase and is produced by recombinant DNA technology using mammalian Chinese Hamster Ovary (CHO) cell culture
Pharmacotherapeutic groupOther alimentary tract and metabolism products, enzymes
ATC codeA16AB08
Target of antibody
General functionGalsulfase 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)
Short description
Pharmacodynamic properties
(Mechanism of action; Source EMA document)
Galsulfase is an enzyme replacement therapy. Enzyme replacement therapy provides patients with the enzyme they are lacking. The active substance in Naglazyme, galsulfase, is a copy of the human enzyme N-acetylgalactosamine 4-sulfatase. Naglazyme helps to break down the GAGs and stop them building up in the cells. This can improve the symptoms of MPS VI, including the ability of patients to move about.
Pharmacodynamic properties (Pharmacodynamic effects; Source EMA document)In studies, the most common side effects with Naglazyme (seen in more than 1 patient in 10) were ear pain, dyspnoea (difficulty breathing), abdominal pain and general pain. Patients can also have reactions to the infusion (such as fever, chills, rash and hives). Naglazyme should not be used in people who may be hypersensitive (allergic) to galsulfase or any of the other ingredients.
Original license holder
Marketing authorisation numbersEU/1/05/324/001
Marketing authorisation holderBioMarin International Limited Shanbally, Ringaskiddy, County Cork, P43 R298 Ireland
Name of the manufacturer of the biological active substanceBioMarin Pharmaceutical Inc.
46 Galli Drive, Novato, CA 94949
United States of America
Name and address of the manufacturer(s) responsible for batch releaseBioMarin International Limited Shanbally, Ringaskiddy County Cork, P43 R298 Ireland
Max shelf life3 years
Storage conditions2°C - 8°C
List of excipientsSodium chloride - Sodium phosphate monobasic, monohydrate - Sodium phosphate dibasic, heptahydrate - Polysorbate 80 - Water for injections