Shire plc Seeks Fast-Track Approval for Fabry Disease Drug

Hundreds of Fabry disease patients sickened because of a U.S. shortage of a drug that keeps them alive are hopeful they soon may get access to a medication previously available only overseas. The biopharmaceutical company Shire announced that it will fast-track its drug, Replagal, for Food and Drug Administration (FDA) approval so American patients can have access to it. The drug has been available for the last decade in 46 countries, and about 140 patients with the disease in the United States are receiving Replagal through an investigational clinical trial sanctioned by the FDA.