CSL Behring Receives European Health Authorities’ Approval of Berinert® for Short-Term Prophylaxis in Adults and Children
Expanded label approved in 23 European countries for treatment and pre-procedure prevention of acute episodes of hereditary angioedema
Marburg, Germany — 16 April 2013
CSL Behring today announced that European health authorities have approved an extended use of Berinert®, a C1-esterase inhibitor (C1-INH) concentrate, for pre-procedure prevention (short-term prophylaxis) of acute episodes of hereditary angioedema (HAE), in adult and pediatric patients undergoing medical, dental or surgical procedures. HAE is a rare, serious and sometimes life-threatening genetic disorder.
“This important approval supports the established treatment recommendations for the use of C1-INH concentrate as first-line therapy for the prevention of potentially life-threatening HAE attacks triggered by surgical or dental procedures,” said Professor Konrad Bork, M.D., Department of Dermatology, Johannes Gutenberg University, Mainz, Germany. “I am very pleased, as with this expanded indication of Berinert, we now have the first approved preventive therapy to protect children with this hereditary condition who are undergoing surgery,” commented Inmaculada Martinez-Saguer, M.D., Hämophilie Zentrum Rhein Main, Mörfelden–Walldorf, Germany.
In addition to short-term prophylaxis, Berinert is indicated in Europe for the treatment of acute attacks of HAE at all body sites in adults and children. The therapy is also approved for self-administration by intravenous infusion for eligible and trained patients. Clinical studies have shown that intervention with Berinert at the onset of an HAE attack brings significantly faster relief to a patient and reduces the severity of the attack compared to placebo.
“CSL Behring is pleased to provide Berinert to HAE patients in Europe as treatment for acute attacks and now as preventive therapy for those undergoing procedures like tooth extractions,” said Val Romberg, Senior Vice President, Research and Development for CSL Behring. “As part of our ongoing commitment to advance the care and improve the lives of people with rare and serious disorders, we are continuously enhancing our product portfolio with new therapies and approved new uses for established products such as Berinert.”
CSL Behring has marketed C1-INH concentrate in Germany for more than 30 years. In the United States, Berinert is approved for the treatment of acute abdominal, facial or laryngeal attacks of HAE in adolescent and adult patients, and for self-administration by trained patients. CSL Behring also markets Berinert in Argentina, Australia, Canada, Israel, Japan and Russia and is seeking marketing authorization in several additional countries in Asia, Central America and South America.
About Hereditary Angioedema
HAE is a rare genetic disorder caused by a deficiency of C1-INH. It is inherited in an autosomal dominant manner. Symptoms of HAE include episodes of edema, or swelling, in the hands, the feet, the face, the abdomen, and/or the larynx. 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. Diagnosis of HAE requires a blood test to confirm low or abnormal levels of C1-INH.
For further information about HAE, please visit the website of the International Patient Organization for C1-Inhibitor Deficiencies, www.HAEI.org and the disease information website www.allabouthae.com.
Berinert is a highly purified, human, plasma-derived C1-esterase inhibitor (C1-INH) concentrate that rapidly treats the fundamental cause of hereditary angioedema (HAE) symptoms by providing C1-INH deficient patients with the missing human protein. Berinert is a unique HAE therapy because of its reliable record of proven efficacy and safety in over 30 years of international clinical use in more than half a million treatments.
About CSL Behring
CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of immune deficiency disorders, hereditary angioedema, haemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Other products are used for the prevention of hemolytic diseases in the newborn, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, CSL Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit
Sheila A. Burke, Director, Communications & Public Relations
Worldwide Commercial Operations CSL Behring
Sheila Burke at cslbehring.com