-
FDA panel recommends approval of Shire's Firazyr
DUBLIN — A Food and Drug Administration expert panel has recommended approval of a drug made by Shire for a rare immune system disorder, the drug maker said.
Shire said the FDA’s Pulmonary-Allergy Drugs Advisory Committee recommended approval of Firazyr (icatibant) for treating acute hereditary angioedema attacks in adults. The committee also voted 11-1 to recommend approval of self-administration of the drug by patients.
HAE is a genetic and potentially fatal immune system disorder that causes swelling of the face and airways and result in airway blockage.