Tretten approved for rare genetic clotting disorder

On December 23, the U.S. Food and Drug Administration approved Tretten (coagulation factor XIII A-subunit [recombinant]) 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 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 from Novo Nordisk, Inc.

See the FDA press release here