Dec 23 The U.S. Food and Drug Administration said on Monday it has approved Novo Nordisk's drug Tretten to prevent bleeding in patients with a rare blood clotting disorder known as congenital Factor XIIIA-subunit deficiency.
Patients with the disorder do not make enough of the Factor XIII protein that is important for normal blood clotting, the FDA said. Factor XIII is composed of subunits A and B. Factor XIII deficiency is usually caused by a deficiency of the A subunit.
Tretten was studied in 77 patients with the disorder and was effective in preventing bleeding in 90 percent of the patients when given monthly, the FDA said. Side effects included headache, pain in the extremities and at the injection site.