Shire plc Withdraws FDA Application For Fabry Drug-Reuters

Reuters reported that Shire plc has pulled its application to the U.S. Food and Drug Administration for approval of its drug to treat Fabry disease, a rare genetic disorder, because the agency likely will require more clinical studies, the Company said on March 14, 2012. Shire said the FDA did not express concerns over Replagal's safety. But recent interactions with the FDA have led the Company to believe that the agency will require additional controlled trials for approval. The Company also said the likely additional studies would cause a significant delay, and an approval of Replagal for U.S. patients would only be possible in the distant future.