Aldurazyme "complete response"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
BioMarin/Genzyme receive "complete response" letter for enzyme replacement therapy Aldurazyme (laronidase) Jan. 28. BioMarin says the letter requires the companies to provide additional information on three issues: postmarketing commitments, final product labeling and completion of the manufacturing inspections process. FDA's Endocrinologic & Metabolic Drugs Advisory Committee voted unanimously Jan. 15 that Aldurazyme had shown efficacy in treating mucopolysaccharidosis I