SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment made by Danish drug maker Novo Nordiskfor a rare, genetic bleeding disorder, the agency said Monday.
The FDA announced the approval of Tretten (coagulation factor XIII A-subunit [recombinant]), calling it the first recombinant product for routine prevention of bleeding in adults and children with congenital factor XIII A-subunit deficiency. Factor XIII is a protein involved in blood clotting, and patients with the condition don't make enough of it. The protein comprises two subunits, A and B; most cases of factor XIII deficiency result from a deficiency of the A-subunit. According to the National Hemophilia Foundation, factor XIII deficiency may be the rarest of all factor deficiencies, affecting one-in-5 million people.
"The approval of this product provides another therapeutic option for the prevention of bleeding in patients with factor XIII A-subunit deficiency," FDA Center for Biologics Evaluation and Research director Karen Midthun said. "Without treatment, people with this rare condition are at risk for serious and life-threatening bleeding."