Shire Pharmaceuticals Drug for Rare Swelling Worked in Trial: FDA

Shire Plc's drug to treat severe swelling caused by a rare genetic disorder showed effectiveness in a key clinical trial, U.S. Food and Drug Administration staff said on Tuesday. The injected drug, Firazyr, is under U.S. review for treating attacks suffered by patients with hereditary angioedema. FDA staff issued a report on the drug, which is approved in other countries, ahead of a federal advisory committee meeting to review the medicine on Thursday. The clinical trial, known as FAST-3, was conducted to address the FDA's concerns over the drug's efficacy from two earlier studies. The agency declined to approve the drug in April 2008, citing clinical deficiencies.

Back to news