EMA advises switching patients off Genzyme's Fabrazyme because of shortages

The European Medicines Agency has advised physicians to consider switching patients with Fabry's disease from Genzyme's Fabrazyme (agalsidase beta) onto alternative enzyme replacement therapies such as Shire's Replagal (agalsidase alfa) in light of continued product shortages.

Replagal has been approved in the EU since 2001 for Fabry disease, a rare genetic lysosomal storage disease, but is still unapproved in the US. Back in 2003, the US FDA denied approval for Replagal after a panel of experts voted that it had not demonstrated efficacy in clinical trial. It was resubmitted with the FDA last year (