The FDA has approved Tretten (coagulation factor XIII A-subunit [recombinant]; Novo Nordisk) for use in the routine prevention of bleeding in adults and children who have congenital Factor XIII A-subunit deficiency, a rare clotting disorder.
Tretten is the first recombinant product approved for this indication.
Tretten is a recombinant analog of the human Factor XIII A-subunit that is produced in yeast cells and then further purified. It is a sterile freeze-dried powder that is reconstituted for IV administration.
The efficacy of Tretten was evaluated in a Phase 3 trial that enrolled 77 patients with congenital Factor XIII A-subunit deficiency.Treatment with Tretten prevented bleeding in 90% of the patients when administered monthly.
Tretten is expected to be available in early 2014.
For more information call 800) 727-6500 or visit NovoNordisk.com.