The shortage of Genzyme's Fabry disease treatment Fabrazyme is driving regulatory action in Europe. The European Medicines Agency now recommends that doctors return to prescribing the full dosage.
It had previously recommended use of a lower dose to help stretch supplies, which had dwindled due to Genzyme's shutting of a Boston-area plant following a viral contamination. But the regulator is now seeing an increase in adverse events that corresponds with the number of patients on the lower dose.
The full-dose recommendation is a problem for Genzyme, which is fighting its way back from the plant shutdown under a consent decree with the FDA. It's now at about 60 percent of production capacity, according to the company. The recommendation may drive patients to competing drug Replagal from Shire.
For its part, the regulator "remains concerned about the continued supply shortages," according to a statement. It is "monitoring the implementation of their improvement measures."
- here's the EMA statement