Marburg, Germany (ots/PRNewswire) -
- Self-administration of C1-Esterase Inhibitor is now approved
in 23 European countries for treatment of Hereditary Angioedema, a rare and
sometimes life-threatening conditionCSL Behring [http://www.cslbehring.com ] today announced that
European health authorities have approved self-administration of
Berinert(R), 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,
http://www.haei.org and the disease information website
http://www.allabouthae.com.
About Berinert(R)
Berinert(R) 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
http://www.cslbehring.com.
Media contact: Sheila Burke, CSL Behring, +1-610-878-4209 (US)
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