CSL Behring announced that the FDA has approved an expansion of the indication for Corifact (Factor XIII concentrate [human]) infusion, to include the peri-operative management of surgical bleeding in adult and pediatric patients with congenital factor XIII deficiency. Corifact is a fibrin-stabilizing factor concentrate that provides both A- and B-subunits to protect against FXIII deficiency.
The approval of 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 (n=20).
Corifact is already indicated for routine prophylactic treatment of congenital Factor XIII (FXIII) deficiency.
For more information call (800) 504-5434 or visit www.corifact.com