FDA Denies Approval for Genzyme Corp’s Lumizyme to Treat Pompe Disease
Finance World News Update by EQUITIES Magazine
Beverly Hills 11/16/2009 05:31 PM GMT (TransWorldNews)
Shares of Genzyme were up more than one percent this morning despite the news that U.S. health regulators denied approval for the company’s Lumizyme to be used in the treatment of Pompe disease.
The U.S. Food and Drug Administration said that Gensyme should satisfactorily resolve deficiencies at its Allston Landing manufacturing plan before the drug can be approved. Genzyme said that deficiencies were mainly related to the fill-finish capabilities at the facility.
Genzyme is moving quickly to address the deficiencies cited by the FDA, ceasing production of Lumizyme at the Allston facility and transitioning all patients worldwide to the product produced at a larger scale in its facility in Geel, Belgium.
Genzyme was in the news last week because of the FDA’s discovery of trash in some of the drugs the biotechnology firm makes to treat rare enzyme disorders.
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