ROCKVILLE, Md -- October 12, 2009 -- The US Food and Drug Administration (FDA) has approved C1-esterase inhibitor (Berinert) for the treatment of acute abdominal attacks and facial swelling associated with hereditary angioedema (HAE) in adults and adolescents.
"[C1-esterase inhibitor] will enhance the treatment options for individuals who experience acute abdominal attacks and facial swelling associated with hereditary angioedema," said Karen Midthun, MD, FDA's Center for Biologics Evaluation and Research, Rockville, Maryland.
C1-esterase inhibitor is a protein product derived from human plasma. It regulates clotting and inflammatory reactions that, when impaired, can lead to local tissue swelling.
In a clinical trial of 124 adults and adolescents with C1 esterase inhibitor deficiency, the protein was shown to be effective at treating the symptoms of acute moderate to severe abdominal attacks and facial swelling in patients with HAE.
The protein is contraindicated in patients with a history of life-threatening hypersensitivity reaction to C1 esterase inhibitor preparations.
The most serious adverse reaction reported in clinical studies was an increase in the severity of pain associated with HAE. The most common adverse reactions included subsequent HAE attack, headache, abdominal pain, nausea, muscle spasms, pain, diarrhoea, and vomiting.
SOURCE: US Food and Drug Administration
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