Berinert Approved for Abdominal Attacks, Facial Swelling Associated With Hereditary Angioedema

The FDA has approved Berinert, the first treatment for acute abdominal attacks and facial swelling associated with hereditary angioedema, a rare and potentially life-threatening genetic disease.
Berinert is approved for adults and adolescents with hereditary angioedema, which can occur spontaneously or during stress, surgery or infection in patients diagnosed with the disease. The symptoms during abdominal attacks include severe abdominal pain, nausea, vomiting, cramps and diarrhea.

"Berinert will enhance the treatment options for individuals who experience acute abdominal attacks and facial swelling associated with hereditary angioedema," said Karen Midthun, MD, acting director of the FDA's Center for Biologics Evaluation and Research.

Berinert 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, Berinert was shown to be effective at treating the symptoms of acute moderate to severe abdominal attacks and facial swelling in patients with hereditary angioedema.

Patients with a history of life-threatening hypersensitivity reaction to C1 esterase inhibitor preparations should not use the medication.  The most serious adverse reaction reported in clinical studies was an increase in the severity of pain associated with hereditary angioedema. The most common adverse reactions include subsequent hereditary angioedema attack, headache, abdominal pain, nausea, muscle spasms, pain, diarrhea and vomiting.

Contact:
Shelly Burgess
301-796-4651
shelly.burgess@fda.hhs.gov