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.

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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. 

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