US FDA approves CSL Behring's Corifact; warns on pre-term use of terbutaline

The US Food and Drug Administration has approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency. Corifact is manufactured by CSL Behring of Marburg, Germany, a global leader in the plasma protein biotherapeutics industry.

Patients with congenital Factor XIII deficiency do not make enough Factor XIII, a substance that circulates in the blood and is important for normal clotting. Without treatment, people with the condition are at risk for life-threatening bleeding.

Congenital Factor XIII deficiency is rare and affects 1 out of every 3 million to 5 million people in the United States. The deficiency may lead to soft tissue bruising, mucosal bleeding and fatal intracranial bleeding. Newborns with Factor XIII deficiency may have umbilical cord bleeding. “This product helps fill an important need,” said Karen Midthun, Director of the FDA’s Center for Biologics Evaluation and Research.