Restart of Production at Genzyme's Allston Facility - But no LumizymeRestart of Production at Genzyme's Allston Facility - But no Lumizyme
September 23, 2009
Lumizyme is the name of alglucosidase alfa for the U.S. market, to be approved by the FDA.
Good news: Cerezyme and Fabrazyme are produced again in Allston, and the Gaucher and Fabry community can expext the end of supply constraints soon. A Genzyme press release states that "all six bioreactors at the Allston plant are fully operational", "Cerezyme production is proceeding on track, with four bioreactors producing", and that there is "output from the two Fabrazyme bioreactors".
What's the bad news about that? All six bioreactors are in use, and none is available for the production of Lumizyme anymore. One question remains unanswered: Do U.S. patients (if not in the MTAP program) now have to wait until the drug from the production in the 4,000 L process in Belgium is approved by the FDA for the U.S market and commercially available?