Last month CSL Behring announced that the US Food and Drug Administration (FDA) has approved an expansion of the indication for Corifact®, a human plasma-derived factor XIII (FXIII) concentrate, to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency. In 2011, Corifact became the first and only FXIII concentrate approved in the US for the routine prophylactic treatment of congenital factor XIII deficiency.
FXIII deficiency is extremely rare. The condition affects an estimated one in 2 million people. Approximately 150 people in the US have the disorder. Deficiencies of FXIII can cause clots to remain unstable and sometimes break down, causing recurrent bleeds. The condition is often associated with trauma. Individuals with the severe form of the disease are at a higher risk of head bleeds with or without trauma. Women who go untreated risk spontaneous abortion; men with the deficiency may show signs of infertility. The most common characteristics include soft tissue bleeds, menorrhagia, joint bleeding, and persistent bleeding during circumcision or at the site of the umbilical cord.
“FDA’s decision to approve Corifact for management of peri-operative bleeding in people with congenital factor XIII deficiency is an important advance that illustrates CSL Behring’s ongoing commitment to those with rare and serious medical conditions who rely on our lifesaving therapies,” said Lynne Powell, Senior Vice President, North America Commercial Operations at CSL Behring.
Source: CSL Behring news release dated February 28, 2013 and Bizjournals.com, March 1, 2013