FDA grants CSL Behring marketing approval for Corifact in treatment of congenital FXIII deficiency

CSL Behring announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Corifact™, Factor XIII Concentrate (Human), for the routine prophylactic treatment of congenital factor XIII (FXIII) deficiency.  Corifact, already available for use in 12 countries throughout the world under the trade name Fibrogammin®- P, is the first and only FXIII concentrate approved in the U.S.

Congenital FXIII deficiency, also known as fibrin-stabilizing factor deficiency, is a rare and potentially life-threatening bleeding disorder in which blood clots normally, but the clots formed are unstable, leading to recurrent bleeding.  It is estimated that the condition affects one person in two million, with an incidence in the U.S. of approximately 150 people.  

"FDA approval of Corifact is a very special opportunity to make a positive difference in the lives of people who need our safe, high-quality therapies, while continuing to enhance our extensive portfolio of products for people with bleeding disorders," said Lynne Powell, CSL Behring Senior Vice President, North America Commercial Operations. "Corifact is the fourth new product that CSL Behring has brought to the U.S. market in the past two years.  This represents our ongoing commitment to developing products for the treatment of rare and serious diseases."

Symptoms of congenital FXIII deficiency include bleeding from the umbilical cord after birth, poor wound healing, miscarriages, subcutaneous bleeding, and excessive bleeding in joints and muscles following trauma. Patients lacking the FXIII protein are also at high-risk for intracranial hemorrhage (ICH), bleeding inside the skull that can be life-threatening. Studies have shown that between 25 and 60 percent of FXIII-deficient patients will experience an ICH at least once during their lifetime.  For a doctor to accurately diagnose FXIII deficiency, specific blood testing and detailed family history are necessary.

SOURCE CSL Behring