Genzyme’s Thyrogen Production Delayed

Genzyme Corp. has encountered a manufacturing problem during the fill/finish stage of production of Thyrogen at its Allston, MA plant. As a result, a shortage of the thyroid medicine for Fabry’s disease is expected. The problem led to the rejection of a single lot of the drug because of a quality issue. Genzyme plans to fill and finish all future lots of Fabrazyme at a contract manufacturing facility operated by Hospira Inc., which already handles a large portion of Fabrazyme’s fill/finish.

Lori Gorski a spokeswoman for Genzyme stated that bulk drug production for both Fabrazyme and Cerezyme is proceeding successfully at the plant. One of the Contingent Value Rights in Sanofi’s acquisition of Genzyme is tied to a production quote of Fabrazyme.

According to the company, the rejected lot will cause some patients to delay treatment, while others may miss doses in coming months. Because of the shortages, the FDA has allowed Shire’s Fabry drug Replagal to be used under a special protocol, despite not being approved for marketing. Replagal is approved in Europe, and Shire has plans to file with the FDA.


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