FDA Grants Expanded Indication Approval for CSL Behring’s Corifact
- By BSTQ Staff
The U.S. Food and Drug Administration (FDA) has approved an expanded indication for CSL Behring’s Corifact, factor XIII (FXIII) concentrate (human) to include the perioperative 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 U.S. for the routine prophylactic treatment of congenital FXIII deficiency. The expanded indication is based on use of Corifact in perioperative situations as part of both a 12-month, prospective, open-label, multi-center efficacy and safety study, as well as a nine-year investigator-initiated clinical study. In total, 20 patients received perioperative management with FXIII with neither treatment-related adverse events nor investigator-assessed serious adverse events.
Corifact, an intravenous infusion given approximately every 28 days, is a fibrin-stabilizing factor concentrate that provides both A- and B-subunits to protect against FXIII deficiency. It is packaged as lyophilized powder in a single-use vial with high stability and a long shelf life of up to six months at room temperature and 24 months when refrigerated. Corifact also has a low infusion volume, which can help reduce administration time.
