EMA Recommends Shire Drug Because of Continued Fabrazyme Shortage

Following the news that the current supply of Genzyme's (Cambridge, MA) Fabrazyme (agalsidase beta) will not be sufficient to address the needs of the nearly 600 Fabry patients receiving the treatment in Europe, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the use of alternate Fabry treatments, such as Replagal, manufactured by Shire (Dublin, Ireland).

The CHMP is recommending that no new patients be started on Fabrazyme. For patients receiving a dose of Fabrazyme <1 mg/kg every other week, the committee says physicians should consider switching to an alternative treatment, such as Shire's Replagal. Patients currently treated with Fabrazyme at the recommended dose of 1 mg/kg every other week should continue on this dosing regimen, according to the guidelines.

These recommendations are temporary and do not change the currently approved product information for Fabrazyme.

The supply shortage of Fabrazyme began in June 2009 and was caused by a series of manufacturing problems at the production site in Allston Landing, MA. Because the current productivity at Allston Landing is still lower than expected, supply of Fabrazyme will not return to normal before the end of this year, according to Genzyme.

The CHMP says it remains concerned about the continued supply shortages of Genzyme's medicines. It currently is assessing proposals for improvement measures put in place by Genzyme to prevent similar manufacturing and quality problems in the future, and is closely monitoring the implementation of these measures.

Previous coverage:
Genzyme Expects $175 Million FineGenzyme to Exit Fill-Finish Operations at Allston Landing PlantFDA Takes Enforcement Action Regarding Genzyme's Allston Plant