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

The Shire drug had been seen as a viable alternative, given that Replagal has been available in Europe for more than a decade and is used to treat most Fabry patients worldwide.

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

Last week, an Idaho woman has filed a lawsuit against Genzyme, charging that a long-standing shortage of its Fabrazyme treatment for Fabry disease led to the death of her husband two years ago.

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

Making matters worse, the same panel said that the data for a rival drug for Fabry made by the company's Cambridge, Mass-based neighbor Genzyme (nasdaq: GENZ - news - people ) supported its effectiveness.

FORBES: Magazine Article

Until the FDA approved the Genzyme plant, Fabry patients were clamoring for an alternative, given that Genzyme had instituted a controversial rationing program in the US. Many of these patients were hopeful the FDA would speed approval of the Shire biologic, since the progress surrounding the Genzyme plant was unclear.

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