Genzyme says FDA to make a decision on large scale production of Pompe disease drug by June 17

Genzyme says FDA will make Lumizyme ruling in June

CAMBRIDGE, Mass. — Genzyme Corp. said Thursday the Food and Drug Administration is scheduled to make a decision on its Pompe disease drug Lumizyme by June 17.

The FDA had refused to approve Lumizyme until Genzyme fixed manufacturing problems at a facility in Allston Landing, Mass. Some of the bioreactors at the Boston-area plant contained a virus that slowed down the production of the company’s drugs, which led to a shutdown in production. The company finished restarting production in September.

Genzyme is seeking FDA clearance to market the Lumizyme it produces in 4,000-liter bioreactor tanks at its facility in Belgium. The drug is currently made in smaller bioreactors and sold outside the U.S. under the name Myozyme. Genzyme had also sought approval for a version made in 2,000-liter bioreactors, but decided not to pursue that application after discussions with the FDA.

Pompe disease is an inherited disorder that interferes with muscle development and can cause deadly respiratory problems. Genzyme is able to give the drug to patients for free through a temporary program, but does not have full commercial approval.

Genzyme shares lost 96 cents to $53.89 in morning trading.