Genzyme Corp. said Monday the Food and Drug Administration will not approve the potential Pompe disease treatment Lumizyme until the company fixes manufacturing problems at the company's Boston-area facility.
Pompe disease is a genetic disorder that interferes with muscle development and can cause deadly respiratory problems.
In March, the FDA made a similar statement to the company, saying it wanted Genzyme to fix manufacturing problems at its Allston Landing plant before it would grant marketing approval along with arranging the design of a post-approval study. The key problem involved a virus in the bioreactors, which are used to create living cells, a key component in biotech-based drugs.
While not harmful to people, the virus slowed down the production process. In June, the company had to shut down the Allston facility to clean the viral contamination, impacting production of the enzyme disorder drugs Fabrazyme and Cerezyme.
Separately, on Friday, the FDA said it found tiny particles of trash in drugs made by Genzyme. The particles included bits of steel, rubber and fiber found in vials of drugs. The agency recommended that doctors closely inspect vials for particles before injecting the drugs into patients. The drugs affected include Cerezyme, Fabrazyme, Myozyme, Aldurazyme and Thyrogen, all of which are made in the Allston facility.
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.