Genzyme: FDA now has all data needed to OK Lumizyme

By Marc Songini

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Giant biotech Genzyme Corp. has completed the last documentation necessary in its attempt to get the U.S. Food and Drug Administration to lift its rejection of the drug Lumizyme.

Last March, Cambridge-based Genzyme (Nasdaq: GENZ) announced the FDA had rejected the company’s initial application to market Lumizyme as a treatment for Pompe disease. Lumizyme is identical to the already-approved drug Myozyme, but has been rebranded and is made in larger batches. In its letter to Genzyme, the FDA specified the need for an agreed-upon post-approval verification study and a finalized Risk Evaluation and Mitigation Strategy. There were also concerns over the company’s Allston Landing manufacturing facility and related processes.

Genzyme says it has now submitted the final documentation to address the FDA’s concerns to produce Lumizyme at the 2,000 L bioreactor scale. It has also submitted the clinical data requested by the FDA from Genzyme’s Pompe Registry, which it said will demonstrate the clinical benefit of Lumizyme. Also included in the submission were the Risk Evaluation and Mitigation Strategy and the final label for the product. Genzyme anticipates the filing will be designated as a Class 2 resubmission with a six-month deadline — however, as there is ongoing dialogue between it and the agency, it expects the process to be shorter.

Additionally, Genzyme responded to the FDA warnings about the company’s Allston manufacturing facility. The FDA has begun inspections at the plant to verify the deficiencies have been addressed.

Genzyme had 2008 revenue of $4.6 billion and a profit of $421 million.

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