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Print Edition StoriesMonday, November 16, 2009
FDA rejects Genzyme’s Pompe disease drug again
By Mass High Tech staff
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Following an initial rejection in March from the U.S. Food and Drug Administration for its Lumizyme treatment of Pompe disease, Genzyme Corp. has now reported its second rejection of the treatment. The Cambridge biotech, which has been steeped in negative news lately, received a letter from the FDA citing the company’s “deficiencies related to the Allston Landing manufacturing plant.”
Genzyme officials noted the deficiencies were related to the Allston plant’s finishing capabilities, which the company said it will address by adding internal controls, updating the filling and finishing capabilities in Allston, and using contract manufacturers and Genzyme’s own Ireland manufacturing plant.
Genzyme was forced to shut down its Allston manufacturing facility in the summer due to the discovery of a virus.
The company no longer produces Lumizyme at the Allston plant and, instead, has moved its production to its Geel, Belgium, location. Genzyme said that the FDA stated that satisfactory resolution of deficiencies related to the Allston Landing manufacturing plant are required before the Lumizyme application can be approved.
The FDA’s initial rejection of Lumizyme came before the Allston plant shutdown and noted the need for an agreed-upon post-approval verification study and a finalized Risk Evaluation and Mitigation Strategy. The rejection notice included concerns of the Allston plant’s process controls, production equipment maintenance and microbiological monitoring and controls. Genzyme said it believes the other elements of the March review, such as the Risk Evaluation and Mitigation Strategy (REMS), the product label, and post-marketing requirements, “have been satisfactorily addressed.”
Genzyme’s (Nasdaq: GENZ) Lumizyme is the same drug as its already approved drug Myozyme, simply re-branded as it is now made in larger batches at a time.
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