FDA Advisory Panel Recommends Approval of Hereditary Angiodema Rx

A Food and Drug Administration advisory committee June 23 recommended approval of injectable icatibant for treatment of acute attacks of hereditary angioedema (HAE) in patients 18 years old and older, Shire plc said in a statement.

Icatibant, also known by the brand name Firazyr, is an investigational drug developed by Shire Human Genetic Therapies for treating HAE, a rare disease caused by low levels or a dysfunction of the C-1 esterase inhibitor (C1-INH). The ailment is characterized by extremely painful, debilitating, and sometimes fatal swelling of the extremities, face, genitals, abdomen, and laryngeal tract.

The Pulmonary-Allergy Drugs Advisory Committee voted ...