Shire plc Drops After Pulling US Application for Replagal, Move Gives Sanofi (France) (SAN.PA) a Boost  
3/15/2012 7:40:13 AM

Shire Plc (SHP) fell in London trading after withdrawing a U.S. application for approval of its Replagal drug for a rare genetic disorder. The Food and Drug Administration, which was scheduled to make a decision on the drug in May, will probably now require additional trials of Replagal before approving it as a treatment for Fabry disease, the Dublin-based company said in a statement late yesterday. “An approval of Replagal for U.S. patients would only be possible in the distant future,” Shire said in the statement. The decision won’t affect financial forecasts for this year, the company said.