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Genzyme/BioMarin Aldurazyme approval

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Genzyme/BioMarin's orphan drug Aldurazyme (laronidase) clears FDA April 30 for treatment of the lysosomal disorder mucopolysaccharidosis I, based on a 26-week, 45-patient Phase III study. Labeling states that "Aldurazyme has been shown to improve pulmonary function and walking capacity [but] has not be evaluated for effects on the central nervous system manifestations of the disorder." Phase IV commitments include a patient registry, testing of urinary glycosaminoglycans and antibody levels, and assessment of a possible correlation "between endogenous enzyme activity and patient antibody responses and infusion reactions"; a dose optimization study is also planned. May launches are expected for Aldurazyme and Genzyme's Fabrazyme, which cleared FDA April 2

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