FDA expands indication for Lumizyme in Pompe Disease-Genzyme/Sanofi

The FDA has approved a supplement to expand the indication for Lumizyme (alglucosidase alfa), from Genzyme/Sanofi. Lumizyme manufactured at the 4000L scale is now indicated for all Pompe patients of any age or phenotype. The approval of this indication is now consistent with that of the rest of the world, where alglucosidase alfa manufactured at the 4000L is the only scale available. Previously, in the United States, Lumizyme had been approved only for patients with late onset Pompe disease.

In the US, alglucosidase alfa is manufactured at two different production scales. Alglucosidase alfa manufactured at the 160L scale (initial pilot scale) has a brand name of Myozyme (alglucosidase alfa) and alglucosidase alfa manufactured at the 4000L (final manufacturing scale) has a brand name of Lumizyme. Lumizyme is approved in more than 65 countries.