CSL Behring recently announced that the US Food and Drug Administration (FDA) has approved an expanded indication of Corifact to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital factor XIII (FXIII) deficiency.
Corifact, Factor XIII Concentrate (Human), became the first and only FXIII concentrate approved in the US in 2011 for the routine prophylactic treatment of congenital factor XIII deficiency. Congenital FXIII deficiency is a rare bleeding disorder where blood clots normally, but unstably, resulting in recurrent bleeding. This is a potentially life-threatening disorder that affects an estimated one person in two million. According to CSL Behring, the disorder affects approximately 150 people in the US.
The approval of expanded use of Corifact is based on a 12-month, prospective, open-label, multicenter efficacy and safety study as well as a nine-year investigator-initiated clinical study. In the study, 20 patients received peri-operative management with FXIII. Throughout the study, no treatment-related adverse events or investigator-assessed adverse events were reported.
“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,” Lynne Powell, Senior Vice President, North America Commercial Operations at CSL Behring said.
Corifact is an intravenous infusion that is given every 28 days. It has shown in clinical studies to immediately increase FXIII levels in the blood. The safe and effective use of the drug was supported in the post-marketing commitment trial under the FDA’s accelerated approval regulations for Corifact. It is available in more than ten countries outside the US under the trade name Fibrogammin P.
Source: CSL Behring
Last Updated: 3/1/13; 11:20AM EST