KING OF PRUSSIA, Pa.
Feb. 28, 2013
announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the indication for Corifact
, Factor XIII Concentrate (Human), to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital factor XIII (FXIII) deficiency. In 2011,
became the first and only FXIII concentrate approved in the U.S. for the routine prophylactic treatment of congenital factor XIII deficiency.
Congenital FXIII 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 prevalence in the U.S. of approximately 150 people.
The expanded indication is based on use of
in peri-operative situations as part of both a 12-month, prospective, open-label, multicenter efficacy and safety study as well as a nine-year investigator-initiated clinical study. In total, 20 patients received peri-operative management with FXIII. Neither treatment-related adverse events nor investigator-assessed serious adverse events were reported.
The post-marketing commitment trial further supports the safe and effective use of
in the clinical setting and fulfills CSL Behring's post-marketing commitment, under the FDA's accelerated approval regulations, for
"FDA's decision to approve
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
, Senior Vice President, North America Commercial Operations, CSL Behring.
About Corifact ®
, an intravenous (IV) infusion given approximately every 28 days, is indicated for routine prophylactic treatment and peri-operative management of surgical bleeding in adult and pediatric patients with congenital FXIII deficiency.
is a fibrin-stabilizing factor concentrate that provides both A- and B-subunits to protect against FXIII deficiency. Clinical studies have shown that
immediately increases FXIII levels in the blood.
is dosed, depending on the patient's weight, to maintain trough FXIII levels between 5 and 20 percent of normal.
is packaged as lyophilized powder in a single-use vial with high stability and a long shelf life. The concentrate is stable for up to six months at room temperature (25 degrees C) and 24 months when refrigerated (2-8 degrees C).
also has a low infusion volume, which could help reduce administration time.