AMA Morning Rounds: Genzyme expects Pompe drug determination

The AP (1/21) reported, "Genzyme Corp. said Thursday the Food and Drug Administration is scheduled to make a decision on its Pompe disease drug Lumizyme [alglucosidase alfa] by June 17." The agency "had refused to approve Lumizyme until Genzyme fixed manufacturing problems at a facility in Allston Landing, MA," where "some of the bioreactors...contained a virus that slowed down the production of the company's drugs." The drugmaker "is seeking FDA clearance to market the Lumizyme it produces in 4,000-liter bioreactor tanks at its facility in Belgium."

The Boston Business Journal (1/22, Donnelly) reports, "The company said in November it would address the FDA's concerns about the manufacturing processes at the Allston plant by adding internal controls, updating the filling and finishing capabilities and using contract manufacturers and Genzyme's own Ireland manufacturing plant." Since then, "Genzyme has...hired a new senior vice president of global product quality and entered into an agreement with" Hospira Worldwide Inc. "to provide fill and finish manufacturing services." Dow Jones Newswire (1/22, Gryta) also covers the story.