Genzyme has come roaring out of the 2011 GMP-comeback gate by stabilizing the supply of Gaucher disease treatment Cerezyme and eliminating restrictions on its use. "We can now provide Cerezyme as prescribed for all patients currently receiving therapy and we have started to add new patients," trumpets the big biotech.
Inventory rebuilding is in process. And the company promises increased capacity when its new Massachusetts manufacturing plant wins FDA approval, expected this year.
Genzyme announced last November that U.S. patients had returned to normal dosing. The supply had been curtailed in mid-June 2009 when the company's Boston-area plant, now operating under consent decree with the FDA, had closed for viral decontamination. The plant began its comeback with the restart of bioreactors in September 2009.
Meanwhile, the FDA has added Bristol-Myers Squibb's chemo drug BiCNU (carmustine) to its list of drugs in short supply. The entry is for the 100-mg injection. BMS cites unspecified manufacturing delays at contract manufacturer.