ABSTRACT

Description: Fabrazyme is a recombinant human α-galactosidase A. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells. The 429amino acid glycoprotein spontaneously dimerizes, yielding the 100-kDa biologically active enzyme. The product is supplied in a lyophilized form (35 mg/vial) to be reconstituted and diluted before use as an intravenous infusion.

Approval Date: 2001 (E.U.)