Genzyme’s BLA for Lumizyme (alglucosidase alfa) seeking approval for the therapy produced at the 4000 L scale, has received a June 17, 2010 PDUFA date from the FDA. The FDA has classified the resubmission as a class 2 complete response, which carries a six-month review timeframe. This past December Genzyme reopened enrollment in the Alglucosidase Alfa Temporary Access Program (ATAP), a program that provides access to treatment for severely affected adults with Pompe disease prior to commercia...