CSL Behring Receives European Health Authorities’ Approval for Self-Administration of Berinert®
Self-administration of C1-Esterase Inhibitor is now approved in 23 European countries for treatment of Hereditary Angioedema, a rare and sometimes life-threatening condition
MARBURG, Germany — 25 August 2011
CSL Behring today announced that European health authorities have approved self-administration of Berinert®, a C1-esterase inhibitor (C1-INH) concentrate indicated in Europe for the treatment of acute attacks of hereditary angioedema (HAE), a rare, serious, and sometimes life-threatening genetic disorder. The expanded European label allows patients to self-administer Berinert by intravenous infusion, after consultation with a physician and after receiving the appropriate training.
“Once the early signs of an HAE attack begin to emerge, any delay in starting treatment can increase the severity of that attack. This can lead to a patient needing to be hospitalized. However, if a patient administers therapy to himself right away, these problems and others can be averted,” said Associate Professor Wolfhart Kreuz M.D., of the Comprehensive Care Centre for Hereditary and Acquired Angioedema of the Goethe University Hospital in Frankfurt, Germany. “For example, by self-administering, the patient can reduce length of time away from work and school. Self-administration of Berinert supports an individualized therapy concept, thereby increasing patients’ confidence in their ability to self-manage their HAE attacks and improving their quality of life.”
“With the European approval of Berinert for self-administration, physicians and patients have another important option to help reduce suffering caused by HAE,” said Henrik Boysen, Executive Director of HAEi, the international patient organization for C1 inhibitor deficiencies. “It is well known that early treatment dramatically reduces the severity and the duration of a hereditary angioedema attack, and can also be lifesaving. As global patient advocates, we at HAEi very much welcome this new label indication for Berinert and hope that self-administration will become as normal for HAE treatment as it already is for treating haemophilia, another type of rare and serious disorder.”
Berinert is licensed in Europe for treatment of acute HAE attacks at all body sites. Clinical studies have demonstrated 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 that HAE patients in Europe can now self-administer Berinert,” said Ingolf Sieper, Executive Vice President, Worldwide Commercial Operations. “We know that self-administration of Berinert helps restore normality and independence to patients. Our commitment to improve the lives of those who are challenged by rare diseases is underscored by this good news.”
In approving the expanded label for Berinert, the European authorities acknowledge the existing clinical experience and practice over the last 25 years showing the safety and efficacy of self-administration of C1-INH. In 2010, physician experts on HAE published a consensus document in Allergy, Asthma and Clinical Immunology concluding that home therapy and self-administration would allow HAE patients to manage their symptoms more proactively in a way that would maintain patients’ safety and minimize disruptions to their lives.
CSL Behring has marketed C1-esterase inhibitor concentrate in Germany for more than 30 years. In December 2008, the company completed a European Mutual Recognition Procedure (MRP) for Berinert for the treatment of acute attacks of HAE in 23 European countries and was subsequently granted all respective national licenses. In October 2009, the United States Food and Drug Administration approved Berinert for the treatment of acute abdominal or facial attacks of HAE in adolescent and adult patients in the United States. National marketing authorizations were also granted for Berinert in Australia in January 2010, Canada in June 2010, and Israel in January 2011. CSL Behring also markets Berinert in Argentina, Japan and Switzerland.
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 concentrate. As intravenous therapy, it 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 500,000 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 www.cslbehring.com.
Media contact: Sheila Burke, CSL Behring, 610-878-4209 (US)