Genzyme, a Sanofi company, announced today that the US Food and Drug Administration (FDA) has approved its manufacturing plant in Framingham, Mass., for the production of Fabrazyme® (agalsidase beta). Please click here to view the press release. This announcement follows last week’s press release that the EMA also approved the Framingham manufacturing plant for the production of Fabrazyme.
Today’s announcement further supports our ability to return Fabry patients globally to regular dosing in accordance with our previously communicated goal of returning all patients to unconstrained full supply throughout 2012. Product from Framingham can now support the return of US patients to full doses as planned. Globally, the complete return to normal supply levels of Fabrazyme will begin in the second quarter and continue throughout the year
as Genzyme works to obtain all global regulatory approvals throughout the year and to build inventory.
We will continue to update the Fabry community at a regional/local level about specific Fabrazyme availability. As a reminder, despite this positive step towards resuming a stable supply of treatment, we continue to operate with limited inventory, so any change to our manufacturing plans could affect the availability of product to patients. Please contact your local Genzyme representative or your treating physician with additional questions.
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