Genzyme temporarily halts production of two rare disease drugs

Vous trouverez des articles traitant du même sujet dans la catégorie "A propos des traitements et prise en charge". Liens utiles à la fin des catégories. Ghislaine SURREL maladies-lysosomales-subscribe@yahoogroupes.fr Wednesday June 17, 2009 Genzyme Corporation announced on June 16 that it has decided to temporarily halt production at its Allston Landing manufacturing facility in Allston, Massachusetts. The company stated it detected a virus that interferes with cell growth, called Vesivirus 2117, in one of the six bioreactors at the facility. Genzyme states that it is collaborating with regulatory agencies as it works to resume production, and expects the plant to be fully operational by the end of July. The Allston plant manufactures Cerezyme(imiglucerase) for the treatment of Gaucher diseaseand Fabrazyme (algalsidase beta) for the treatment of Fabry disease. The plant shutdown means there won't be enough of either drug to meet worldwide demand. "The patients who need these therapies are our priority,” Henri A. Termeer, Genzyme’s chairman and chief executive officer, said in a company press release. “We are confident in the quality of the products produced in Allston and in our ability to resolve the issue affecting the plant. The impact will be temporary.” This isn't the first time Genzyme has had problems at the Allston plant. In 2008 the U.S. Food and Drug Administration (FDA) conducted an inspection of the plant and found "significant deviations from current good manufacturing practice" in Genzyme's drug production. On February 27, 2009, the FDA sent Genzyme a warning letter stating that the company had not yet addressed all of the FDA's concerns about the Allston plant. One of the areas of concern was what controls Genzyme was using to protect against microbial contamination at the plant--exactly what has happened with Vesivirus 2117. http://rarediseases.about.com/