Abstract

New BLA for FDA-approved biologic needed The FDA's request for Genzyme to submit a new biologics license application (BLA) for its Pompe disease drug Myozyme raises questions for follow-on product approval in the United States. The lowdown: In April 2006, Genzyme received FDA approval for the recombinant enzyme Myozyme (alglucosidase alpha) — the first therapy approved for Pompe disease — manufactured at a limited capacity of 160 L at their Framingham plant.