CSL Behring Submits BLA Requesting Approval of Human Fibrinogen Concentrate for the Treatment of Congenital Bleeding
King of Prussia, PA — 21 July 2008
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
Sheila A. Burke, Director, Communications & Public Relations
Worldwide Commercial Operations