CSL Behring today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for self-administration of Berinert®, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered therapy indicated for the treatment of acute attacks of hereditary angioedema (HAE), a rare and potentially fatal genetic disorder. With appropriate training from a physician, patients can now self-administer Berinert by intravenous infusion. As part of the label expansion, Berinert is now also indicated to treat life-threatening laryngeal HAE attacks, as well as facial and abdominal attacks.
"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," said Dr. Bruce Zuraw, Professor of Medicine-in-Residence, University of California, San Diego, School of Medicine. "However, if a patient self-administers therapy as soon as symptoms begin to appear, these problems can usually be averted. Clearly, this label expansion for Berinert is an extremely important advance in the on-demand treatment of attacks of HAE. Home-based self-administration provides HAE patients with a great opportunity to improve their lives."
Intervention with Berinert at the onset of an abdominal or facial HAE attack has been shown to provide significantly faster relief to a patient (median onset of relief of 48 minutes in clinical trials, versus more than four hours in placebo group). In a non-placebo extension study, the use of Berinert to treat laryngeal attacks provided a median onset of relief of 15 minutes, which is significant due to the potentially life-threatening nature of these attacks.
CSL Behring 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. Approval of the expanded label for Berinert follows years of clinical experience in Europe establishing the safety and efficacy of self-administration of C1-INH therapy. For further information about Berinert, please visit www.berinert.com.
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 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. Diagnosis of HAE requires a blood test to confirm low or abnormal levels of C1-INH.
About Berinert®
Berinert, C1 Esterase Inhibitor (Human), a pasteurized, nanofiltered, plasma-derived intravenous therapy, treats acute facial, abdominal and laryngeal hereditary angioedema (HAE) symptoms by providing C1-INH deficient adult and adolescent patients with the missing human protein. Without C1-INH, people with HAE suffer from recurrent episodes of rapid swelling of areas of the skin and underlying tissues including the face, mouth, throat and abdomen. CSL Behring has marketed its pasteurized and nanofiltered C1-esterase inhibitor concentrate, Berinert, in Germany for more than 30 years. The product is also approved and marketed in 23 other European countries, the United States, Australia, Canada, Israel, Argentina, Japan and South Korea.
The safety and efficacy of Berinert for prophylactic therapy have not been established. Berinert is contraindicated in individuals with a history of life-threatening systemic reactions, to C1 esterase inhibitor preparations, including anaphylaxis. The most serious adverse reaction reported in subjects who received Berinert in clinical studies was an increase in the severity of pain associated with HAE. In placebo-controlled clinical trial, dysgeusia was the most common adverse reaction reported in over 4 percent of subjects who received Berinert and more frequently than in placebo group. Thrombotic events have been reported in patients receiving C1 esterase inhibitor product, including Berinert, at the recommended dose as well as when used off-label or at higher-than-labeled doses.
Berinert is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated. Please see full prescribing information for Berinert.
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.
Contact:
Sheila A. Burke, Director, Communications & Public Relations
Worldwide Commercial Operations
CSL Behring
610-878-4209 (o)
484-919-2618 (c)
Sheila.Burke@cslbehring.com