New Genzyme Factory Receives FDA Approval

French drugmaker Sanofi's Genzyme unit said Tuesday the Food and Drug Administration has approved a new Massachusetts manufacturing plant to make the Fabry disease treatment Fabrazyme, a move that will help relieve a supply crunch. Genzyme said the plant in Framingham also received European regulatory approval last week.

French drugmaker Sanofi's Genzyme unit said Tuesday the Food and Drug Administration has approved a new Massachusetts manufacturing plant to make the Fabry disease treatment Fabrazyme, a move that will help relieve a supply crunch.

Genzyme said the plant in Framingham also received European regulatory approval last week. The company expects all U.S. patients taking Fabrazyme to return to full dosing by March, and it expects to restore "unconstrained supply" worldwide throughout the year.

Genzyme built the Framingham plant after dealing with manufacturing problems at another location in Allston, Mass. In June of 2009, the company shut down that plant for about three months to clean up viral contamination that had been slowing production of Fabrazyme and Cerezyme, which treats Gaucher disease, an enzyme disorder that can result in liver and neurological problems.

Later that year, the FDA said it found tiny particles of steel, rubber and fiber in Cerezyme and Fabrazyme, among other drugs.

The problems created manufacturing capacity constraints and forced Genzyme to move operations for filling its vials to Ireland.

Genzyme spokeswoman Lori Gorski said the Allston plant is up and running again, and it will focus on Cerezyme. The new location will make Fabrazyme.

Fabry disease is an inherited disorder caused the buildup of a particular type of fat in the body's cells.

 

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