ALDURAZYME SUMMARY
ALDURAZYME® (laronidase) is a polymorphic variant of the human enzyme, (alpha)-L-iduronidase that is produced by recombinant DNA technology in a Chinese hamster ovary cell line. (alpha)-L-iduronidase (glycosaminoglycan (alpha)-L-iduronohydrolase, EC 3.2.1.76) is a lysosomal hydrolase that catalyses the hydrolysis of terminal (alpha)-L-iduronic acid residues of dermatan sulfate and heparan sulfate.
ALDURAZYME is indicated for patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms. The risks and benefits of treating mildly affected patients with the Scheie form have not been established.
ALDURAZYME has been shown to improve pulmonary function and walking capacity. ALDURAZYME has not been evaluated for effects on the central nervous system manifestations of the disorder.
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