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news.The US Food and Drug Administration (FDA) has approved CSL Behring's Corifact, a product intended to prevent bleeding in people with congenital Factor XIII deficiency, a rare genetic defect.
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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.