FDA rejects Genzyme drug
Boston Business Journal
Monday, November 16, 2009, 2:15pm EST | Modified: Tuesday, November 17, 2009, 2:05pm
The U.S. Food and Drug Administration has once again rejected Genzyme Corp.’s Lumizyme treatment of Pompe disease, citing problems with the company’s Allston plant.
The FDA had handed the Cambridge-based biotech an initial rejection in March. Genzyme officials noted the latest rejection was related to the deficiencies in 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 (Nasdaq: GENZ) 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 but has moved production to a plant in Belgium. Genzyme said that the FDA stated that satisfactory resolution of deficiencies related to the Allston manufacturing plant are required before the Lumizyme application can be approved.
Pompe disease is a deficiency of a certain enzyme that helps the body break down glycogen, a complex carbohydrate that is converted to glucose for energy. Without the enzyme, glycogen builds up in the heart and other muscles.
The rejection is the latest bit of bad news for Genzyme. Last week the FDA issued a warning that Genzyme drugs were contaminated with such things as steel fragments and rubber.
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