FDA expands approval of Corifact (CSL Behring) to manage surgical bleeding in adult and pediatric patients with Factor XIII Deficiency

The FDA has approved an expansion of the indication for Corifact (factor XIII Concentrate), from CSL Behring, to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital Factor XIII 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. The expanded indication is based on use of Corifact 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.