FDA panel backs Myozyme 2000 L

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 16-1 Tuesday that Genzyme (NASDAQ:GENZ) has demonstrated the safety and efficacy of Myozyme alglucosidase manufactured in a 2000-liter bioreactor to treat Pompe's disease. Thirteen voting members favored accelerated approval, three favored regular approval and one had no preference. The committee voted 16-0, with one abstention, against restricting Myozyme produced in the 2000-liter facility to adult-onset Pompe's. Instead, there was a consensus in favor of labeling the product for patients with the late-onset form of the disease, with no age restriction. ...