Ironically, the agency encouraged Shire to enter the Fabry disease market in the US in the wake of protracted quality-control problems encountered by Genzyme.

FORBES: Shire Ends Fabry Drug Bid, Giving Sanofi A Boost

Fabrazyme treats Fabry disease, which afflicts some 3, 000 patients worldwide.

FORBES: Magazine Article

In a surprise move, Shire Pharmaceuticals has ended its bid for FDA approval for its Replagal biologic for treating Fabry disease, a rare, but life-threatening genetic disorder.

FORBES: Shire Ends Fabry Drug Bid, Giving Sanofi A Boost