Acelerated appro for Myozyme produced at the 2000 L Bioreactor Scale

US biotechnology firm Genzyme says that the Food and Drug Administration plans an accelerated approval for Myozyme (alglucosidase alfa) produced at the 2000 L bioreactor scale for the treatment of late-onset Pompe disease. The company and the agency first need to agree on the design of a post-approval verification study and the FDA must complete its review of the Risk Evaluation and Mitigation Strategy for the product. Genzyme submitted the REMS earlier this month.

The FDA has classified this submission as a major amendment to the Biological License Application for Myozyme produced at the 2000 L scale, and therefore has extended the Prescription Drug User Fee Act date by 90 days to February 28, 2009. Genzyme will be required to submit the final protocol for the verification study after approval.

Genzyme says it does not expect this extension to affect its 2009 non-GAAP earnings per share. The company reconfirmed its non-GAAP EPS guidance of $4.70 for next year.