The FDA ( Food and Drug Administration ) has approved Firazyr ( Icatibant ) injection for the treatment of acute attacks of a rare condition called hereditary angioedema ( HAE ) in people ages 18 years and older.

hereditary angioedema is caused by low levels or the improper function of a protein called C1 inhibitor, which is involved in regulating how certain immune system and blood clotting pathways function. There is usually a family history of the condition. Fewer than 30,000 people in the United States have hereditary angioedema.

People with hereditary angioedema can develop rapid swelling of the hands, feet, limbs, face, intestinal tract, voice box, or windpipe, which may result in disfigurement, disability, or death. Swelling of the digestive tract may cause abdominal pain, nausea, and vomiting, while airway swelling puts patients at risk of suffocation.

The safety and efficacy of Firazyr was demonstrated in three controlled clinical trials, with open-label extension periods, in which 225 patients received 1,076 doses of 30 mg Firazyr. The median time for patients treated with Firazyr to report onset of symptom relief was two hours compared with almost 20 hours with placebo.

Firazyr is the third drug approved in the United States to treat hereditary angioedema attacks. In October 2009 the FDA approved Berinert ( C1-inhibitor ) to treat facial and abdominal attacks of hereditary angioedema, and Kalbitor ( Ecallantide ) was approved in December 2009 to treat acute attacks of hereditary angioedema in patients ages 16 years and older.

The FDA approved Firazyr with patient counseling information that includes injection instructions. The most common side effects reported by those using Firazyr were injection site reactions, fever, increased liver enzymes, dizziness, and rash.

Source: FDA, 2011

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