Genzyme's Framingham Work Clears Europe Hurdle
Life sciences manufacturer Genzyme has won European regulatory approval to restore normal supply levels of a drug made in Framingham that's used to treat a genetic disorder, the company announced.
Genzyme, which is owned by France-based Sanofi, said the plant makes Fabrazyme, a drug used to treat Fabry disease. The approval comes from the European Medicines Agency, which oversees the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union.
Genzyme said a complete return to normal supply levels of the drug globally are needed, but will take time to get regulatory approvals around the world. The company expects that to occur throughout the year.
"This approval ... represents an important milestone in our manufacturing recovery and path toward unconstrained supply for all patients," said David Meeker, president and CEO of Genzyme, which is based in Cambridge. "Providing the Fabry community with consistent access to treatment, increasing our inventory of Fabrazyme, and working toward all regulatory approvals of our Framingham plant are our highest priorities."
Last year, Genzyme encountered manufacturing problems at its plant in the Allston section of Boston that the company said could cause patients to miss doses of the drug. But the company was waiting on approvals to return to full production at the Framingham plant, located on New York Avenue and built in 2009.
"The EMA approval is an important milestone for Genzyme and a clear indication that our manufacturing recovery is well under way and on track," said Lori Gorski, a spokeswoman for the company. "Our plan has been to return to normal supply during 2012 and now we're another step closer to this crucial goal."
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