FDA Approves Genzyme’s Lumizyme For Treating Late-Onset Pompe Disease

The Food and Drug Administration May 25 announced that it has approved Lumizyme (alglucosidase alfa) for patients ages eight years and older with late-onset (non-infantile) Pompe disease.

Pompe disease is a gene mutation that prevents the body from making an enzyme, or making enough of the enzyme called acid alpha-glucosidase (GAA), which is necessary for proper muscle functioning, FDA said. Lumizyme, which is manufactured by Cambridge, Mass.-based Genzyme, is believed to work by replacing the deficient GAA.

A Genzyme spokeswoman May 25 told BNA that Lumizyme will be priced similarly to Myozyme and to other approved enzyme replacement therapies. Myozyme, ...