US FDA approves Genzyme's Myozyme

US biotechnology major Genzyme says that the Food and Drug Administration has granted marketing approval for Myozyme (alglucosidase alfa), its treatment for patients with Pompe disease, a debilitating, progressive and often fatal disorder affecting fewer than 10,000 people worldwide.

The firm noted that its product is the first ever approved treatment for Pompe disease and the first for an inherited muscle disorder. The agent has received orphan drug designation in the USA, which provides seven years of market exclusivity. Genzyme expects to launch the product there within two weeks. Late last month, it was also approved in the European Union.