KING OF PRUSSIA, Pa., July 21 PA-CSL-Behring-FDA
KING OF PRUSSIA, Pa., July 21 /PRNewswire/ -- CSL Behring announced today
that it has submitted a biologics license application (BLA) to the U.S. Food
and Drug Administration (FDA) requesting approval to market its human
fibrinogen concentrate in the United States for the treatment of congenital
fibrinogen deficiency, a rare bleeding disorder resulting from deficiency of
fibrinogen.
"Submission of the BLA for human fibrinogen concentrate reinforces CSL
Behring's commitment to developing and providing effective therapies for
patients who suffer from coagulation disorders," said Robert Lefebvre, Vice
President and General Manager of U.S. Commercial Operations at CSL Behring.
"We look forward to making this new therapy available in the U.S. upon FDA
approval, and fulfilling a significant unmet medical need for patients with
congenital fibrinogen deficiency."
Fibrinogen, also called Factor I, is a protein needed to form a blood
clot. Fibrinogen levels in plasma determine the potential clotting ability
and activity in the body. Diminished concentrations of fibrinogen limit the
body's ability to form a clot. Normal fibrinogen levels generally indicate
normal blood clotting ability. Rarely, a person may have a normal quantity of
fibrinogen, but the fibrinogen does not function as needed. Symptoms of a
fibrinogen deficiency include excessive bleeding following injury, bruises,
bleeding of the umbilical cord at birth and from the site of the umbilical
stump in a newborn baby, and bone, joint or tissue hemorrhage. A simple blood
coagulation test is needed to determine fibrinogen levels and confirm a
diagnosis.
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
SOURCE CSL Behring
