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CSL Behring HAE drug can now be self-administered
Jan 4, 2012The Food and Drug Administration approved a label expansion Tuesday for CSL Behring ’s Berinert product, a treatment for acute attacks of hereditary angioedema (HAE).
Under the label expansion, patients with appropriate training from a physician can now self-administer Berinert by intravenous infusion. In addition, Berinert is now also indicated to treat life-threatening laryngeal HAE attacks, as well as facial and abdominal attacks.
HAE is a rare and potentially fatal genetic disorder caused by a deficiency of C1-INH. The condition can cause swelling in the face, abdomen, larynx and extremities. Patients who have abdominal attacks of HAE can experience episodes of extreme pain, diarrhea, nausea and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face or throat can result in airway closure, asphyxiation and, if untreated, death. An estimated one in 10,000 to 50,000 people in the United States suffer from HAE.
CSL Behring of King of Prussia, Pa., has marketed Berinert in the United States for the treatment of acute abdominal or facial attacks of HAE in adolescent and adult patients since its FDA approval in October 2009.
Viropharma (NASDAQ:VPHM) of Exton, Pa., has an HAE product in the market, as does Shire (NASDAQ: SHPGY) , a Dublin, Ireland, company that has its U.S. headquarters in Wayne,.
