Aldurazyme Should Be Indicated For Symptomatic MPS I, Cmte. Says
Executive Summary
BioMarin/Genzyme's Aldurazyme should be indicated for symptomatic treatment of mucopolysaccharidosis I, FDA's Endocrinologic & Metabolic Drugs Advisory Committee said Jan. 15
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Biomarin's Aldurazyme (laronidase) receives a complete response letter Jan. 28. FDA asked for more information on "postmarketing commitments, final product labeling, and completion of the manufacturing inspections process," Biomarin said. FDA completed its pre-approval inspections, and no further inspections are scheduled. The company expects Aldurazyme's postmarketing commitments to follow the Endocrinologic & Metabolic Drugs Advisory Committee recommendations of antibody formation monitoring. The committee unanimously recommended FDA approve Aldurazyme as treatment for mucopolysaccharidosis I (1"The Pink Sheet" Jan. 20, p. 18)...