Oct 17, 2008 - Genzyme Corporation (Nasdaq: GENZ) today announced that its U.S. Biologic License Application (BLA) for Myozyme(R) (alglucosidase alfa) produced at the 2000 L bioreactor scale will be discussed this Tuesday, October 21st, at a public meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee in Silver Spring, Maryland. This product is intended for the treatment of Pompe disease, a progressive, debilitating and life-threatening inherited disorder affecting approximately 2,000 people in the United States. The meeting will focus on the clinical outcomes of the Late Onset Treatment Study (LOTS), including statistical analyses of the study results, safety and the indication for alglucosidase alfa.
The details can be read here.
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