EMEA recommends Replagal as alternative Fabry treatment due to Fabrazyme shortage; FDA approves Shire's Daytrana for adolescents

The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) said yesterday that it has been obliged to revise its previous recommendations on the use of Fabrazyme (agalsidase beta) for the treatment of the rare inherited enzyme-deficiency disorder Fabry disease. This follows information from the manufacturer, US biotechnology firm Genzyme, stating that the current supply of Fabrazyme will not address the medical needs of the nearly 600 patients receiving Fabrazyme in Europe today.

The CHMP is recommending that, in situations where alternative treatment is available, no new patients should be started on Fabrazyme. For patients receiving a dose of Fabrazyme less than 1mg/kg every other week, physicians should consider switching to an alternative treatment, such as Replagal (agalsidase alfa), marketed by UK drugmaker Shire and earning sales of $194 million for the company last year. News of the agency's recommendation saw Shire

News of the Committee's recommendations, which are temporary and do not change the currently approved product information for Fabrazyme, saw Shire's shares rise 3% to $5663.91 in mid-afternoon US trading, while those of Genzyme fell 4% to $50.84.