Patients with congenital Factor XIII do not make enough Factor XIII, a substance in the blood that is important for normal clotting, and people with this condition are at risk for life-threatening bleeding.
Corifact is made from the pooled plasma of healthy donors.
The FDA cleared Corifact based on results from a clinical study involving 14 people, including children, with congenital Factor XIII deficiency.
Corifact had received orphan-drug designation by the FDA as it is intended for use in rare disease or condition, and it was approved for marketing under the FDA’s accelerated approval regulations.