Skip to Content

Elaprase FDA Approval History

FDA Approved: Yes (First approved July 24, 2006)
Brand name: Elaprase
Generic name: idursulfase
Dosage form: Injection
Company: Shire plc
Treatment for: Mucopolysaccharidosis Type II

Elaprase (idursulfase) is a purified form of the human lysosomal enzyme iduronate-2-sulfatase produced by recombinant DNA technology. Elaprase is indicated for the treatment of Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II).

Development Timeline for Elaprase

Jul 24, 2006Approval Elaprase Shire plc - Treatment for Hunter Syndrome
May 17, 2006Shire Provides Update on U.S. Marketing Application of Elaprase
Nov 24, 2005Shire Files Elaprase (idursulfase) With the FDA for the Treatment of Hunter Syndrome

Further information

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