CSL Behring Submits BLA Requesting Approval of C1-Esterase Inhibitor for the Treatment of Hereditary Angioedema



    
    Pivotal phase II/III study demonstrates C1-INH is effective treatment for
    acute HAE attacks
    

    KING OF PRUSSIA, Pa., March 6 /CNW/ -- CSL Behring has submitted a
biologics license application (BLA) to the U.S. Food and Drug Administration
(FDA) requesting approval to market its C1-esterase inhibitor concentrate in
the United States for the treatment of hereditary angioedema (HAE), a rare and
serious genetic disorder.  The submission is based on the recently completed
phase II/III prospective, double-blind placebo-controlled International Multi-
center Prospective Angioedema C1-Inhibitor Trial (I.M.P.A.C.T.), the largest
HAE trial ever, that studied the efficacy of pasteurized C1-INH concentrate.
    The proposed indication is for the treatment of acute attacks in patients
with HAE. Currently, there are no specifically-approved therapies for HAE in
North America.
    "Submission of the BLA for C1-INH brings CSL Behring one step closer to
providing therapy for hereditary angioedema," said Val Romberg, Senior Vice
President of Research and Development at CSL Behring. "We are confident that
our expertise in developing and manufacturing plasma-derived protein therapies
will be advantageous in our pursuit of regulatory approval in the United
States."
    HAE is a genetic disorder caused by a deficiency of C1-INH which is
inherited in an autosomal dominant manner.  Symptoms include episodes of edema
or swelling in the hands and feet, the face, the abdomen, and/or the larynx.
Patients who have abdominal attacks can experience episodes of severe pain,
diarrhea, nausea, and vomiting caused by swelling of the intestinal wall.
Attacks that involve the face and larynx 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. There are estimates of 6,000 to
10,000 or more people with HAE in the United States.
    The submission is based on a study of 124 HAE patients with acute,
moderate, or severe abdominal or facial attacks. C1-INH concentrate was
administered at two different doses and compared to placebo. The main study
endpoints were: time to onset of symptom relief from HAE attacks, proportion
of subjects with worsening clinical HAE symptoms, and safety.
    CSL Behring manufactures and sells C1-INH concentrate in Germany,
Austria, Switzerland, and several other countries under the trade name
Berinert(R) P.
    
    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, hemophilia, 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,
ZLB 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
    

    
     Brian Thompson
     MCS
     908-234-9900 (o)
     201-952-5967 (c)
     briant@mcspr.com
    




For further information:

For further information: Sheila A. Burke, Director, Communications & 
Public Relations, Worldwide Commercial Operations, CSL Behring,
+1-610-878-4209,  Sheila.Burke@cslbehring.com Web Site:
http://www.cslbehring.com


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