Skip to main content

Naglazyme FDA Approval History

FDA Approved: Yes (First approved May 31, 2005)
Brand name: Naglazyme
Generic name: galsulfase
Previous Name: Aryplase
Company: BioMarin Pharmaceutical Inc.
Treatment for: Mucopolysaccharidosis Type VI

Naglazyme (galsulfase) is an enzyme-replacement therapy for treatment of mucopolysaccharidosis VI (MPS VI), an inherited, life-threatening lysosomal storage disorder caused by a deficiency of the lysosomal enzyme N-acetylgalactosamine 4-sulfatase (also known as arylsulfatase B).

Development timeline for Naglazyme

May 31, 2005Approval Naglazyme BioMarin Pharmaceutical Inc. - Treatment for Mucopolysaccharidosis VI (MPS VI)
Nov 29, 2004BioMarin Submits U.S. Biologics License Application for Marketing Authorization of Aryplase for MPS VI

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.