EU Drugs Body Says Consider Switching To Shire Fabry Drug
The European Medicines Agency said Friday doctors should
consider switching some patients with a rare genetic disorder to a
drug made by Shire PLC (SHP.LN) because of manufacturing problems
with a rival medicine from Genzyme Corp. (GENZ).
The agency's Committee for Medicinal Products for Human Use said
Genzyme has told it supply shortages of two drugs, Fabryzyme for
Fabry disease and Cerezyme for Gaucher disease, will continue until
at least September 2010 because of a problem with the water system
at a Genzyme plant in the U.S., where production was temporarily
shut down last year due to contamination.
The problem at the plant has been fixed but supplies of both
medicines won't return to normal before the end of September, the
The committee said it is revising guidance given in September
2009 for Fabryzyme patients, which recommended adult Fabry patients
receive a lower dose of the medicine during the shortages.
However, 12% of patients on this lower dose got worse, and the
committee said for such patients doctors should consider restarting
treatment at a higher dose or switching them to alternatives like
Fabry disease and Gaucher disease are rare, inherited conditions
characterized by a build of fats in tissues, causing organ
Company Web site: www.emea.europa.eu; www.shire.com;
-By Jason Douglas, Dow Jones Newswires; 44-20-7842-9272;