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, April 16, 2013
MARBURG, Germany, April 16, 2013 /PRNewswire/ --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
"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., Hamophilie Zentrum Rhein Main, Morfelden–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
"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 www.cslbehring.com.
Media contact: Sheila Burke, CSL Behring 610-878-4209 (US)
SOURCE CSL Behring
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