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FDA Approves Recombinant Product (Tretten) for Clotting Disorder
Treatment prevents bleeding in 90% of patients in clinical study (December 23)
The FDA has approved Tretten, coagulation factor XIII A-subunit (recombinant) (Novo Nordisk), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a clotting disorder known as congenital factor XIII A-subunit deficiency.
Congenital factor XIII deficiency is an extremely rare genetic disorder. Patients with this deficiency do not make enough factor XIII, a protein that circulates in the blood and is important for normal clotting. Factor XIII is composed of two subunits, A and B. Factor XIII deficiency is usually caused by a deficiency of the A-subunit.
Tretten is a recombinant analogue of the human factor XIII A-subunit that is produced in yeast cells and then further purified. It is a sterile freeze-dried-powder to be reconstituted with diluent and injected intravenously. Tretten can be administered by a physician, or it can be self-administered.
The effectiveness of Tretten was studied in 77 patients with congenital factor XIII A-subunit deficiency. The product was effective in preventing bleeding in 90% of the patients when given monthly. Some of the side effects reported in this study were headache, pain in the extremities, and pain at injection site. No abnormal clotting was reported.
Source: FDA; December 23, 2013.