Genzyme Framingham plant now cleared by US and EU regulators

French drug major Sanofi (Euronext: SAN) said yesterday that the US Food and Drug Administration has approved its subsidiary Genzyme’s manufacturing plant in Framingham, Mass, USA, for the production of Fabrazyme (agalsidase beta). This follows the previously announced approval by the European Medicines Agency (EMA) last week.

Genzyme’s shipments of Fabrazyme have been hampered for the past two years as the company recovers from a 2009 viral contamination of equipment at its Allston Landing plant, a situation that has benefitted UK rare diseases drugmaker Shire, which makes an alternative treatment for Fabry disease, Replagal (agalsidase alfa), as well as Vpriv (velaglucerase alfa), which to some extent replaced Genzyme’s Cerezyme (imiglucerase) in type 1 Gaucher disease patients, which was also in short supply.

Since the end of 2010, Although Genzyme has been able to supply Gaucher patients with its Cerezyme drug pretty much as normal since the end of 2010, supply problems have continued for the Fabry drug, meaning patients have been under-treated.