ARTICLE | Clinical News

Firazyr icatibant regulatory update

March 3, 2014 8:00 AM UTC

EMA's CHMP said Shire withdrew an application to extend the label of Firazyr icatibant to treat angioedema caused by the class of drugs known as angiotensin-converting enzyme (ACE) inhibitors. Shire withdrew the application based on CHMP's view that the provided data were not sufficient to address the agency's concerns and that additional data to support approval would not be available within the required timeframe. Shire is conducting a Phase III trial of Firazyr to treat ACE inhibitor-induced angioedema. ...