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Genzyme, a Sanofi company based in Cambridge, has been given the OK from the European Medicines Agency to use its Framingham manufacturing plant to produce Fabrazyme, a treatment for Fabry disease.
The approval comes at a time when Genzyme’s hold on the Fabry disease therapeutics market has slipped following the company’s temporary shutdown of its Allston plant in 2010 and the subsequent FDA enforcement action and shortages of the drugs to treat Fabry disease, as well as Gaucher disease. Since then, U.K.-based Shire plc has taken progressive steps to show that patients can safely transition from Genzyme’s treatments to its own treatments, including its Replagal therapeutic for Fabry disease, which is lining up for production at its Lexington facility.
Fabry disease is an inherited disorder resulting from a type of fat in the body’s cells.
Genzyme has suffered from a number of setbacks with its rare disease therapeutics to treat Fabry disease and Gaucher disease. In March, the company said one lot of its Fabrazyme drug had to be scrapped in the final stages of production at its Allston plant. In September, Genzyme was still struggling to fill orders of Fabrazyme, indicated by a letter to health care providers at the time; at that time, the company said that FDA approval of its Framingham plant would permanently alleviate the Fabrazyme drug shortage.
Genzyme was acquired by Sanofi for $20 billion in April 2011. Last October, it appointed David Meeker as the new CEO.
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