FDA Approves Novo's Tretten For Rare Clotting Disorder

(RTTNews) - The U.S. Food and Drug Administration has approved Tretten, manufactured by insulin maker Novo Nordisk A/S (NVO), to treat congenital Factor XIII A-subunit deficiency, a rare genetic clotting disorder.

Congenital Factor XIII deficiency is a condition in which patients do not make enough Factor XIII, a protein that is important for normal blood clotting. Factor XIII is made up of two subunits, and this deficiency is usually caused by lack of the A-subunit. Tretten has orphan-drug designation for this indication.

Tretten is a recombinant analogue of the human Factor XIII A-subunit that is produced in yeast cells and then further purified, which is a sterile freeze-dried-powder to be reconstituted with diluent and injected intravenously.

The FDA approval was based on a study of 77 patients with congenital Factor XIII A-subunit deficiency in which Tretten proved effective in preventing bleeding in 90 percent of the patients when given monthly.

Novo Nordisk stock closed Monday at $179.90, down $0.12 or 0.07%, on the NYSE.