Genzyme's Lumizyme Faces Delay Over Facility Woes

The FDA has now completed a five-week inspection of the Allston facility, the company said. Genzyme is working with the FDA to fix any remaining problems at the facility.

"Genzyme believes the other elements of the Lumizyme review, such as the Risk Evaluation and Mitigation Strategy (REMS), the product label, and post-marketing requirements, have been satisfactorily addressed," the company said in a statement.

Lumizyme is now being produced at the company's larger-scale facility in Geel, Belgium, in order to meet global demand, the company said.

Shares of Genzyme rose 72 cents to $50 in morning trading.