FDA approves Novo Nordisk’s Tretten to treat rare genetic clotting disorder

The US Food and Drug Administration yesterday (December 23) approved Tretten, coagulation factor XIII A-subunit (recombinant), from Danish insulin giant Novo Nordisk (NOV: N).

This is the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, known as congenital Factor XIII A-subunit deficiency. Tretten received orphan-drug designation for this use by the FDA because it is intended for treatment of a rare disease or condition. Tretten has demonstrated safety and efficacy, offering patients once-monthly dosing with a short infusion time.

$84 million sales by 2018 forecast

The drug is expected to generate sales of $84 million by 2018, according to the average estimate of three analysts polled by Thomson Reuters. As of 2011 estimates, only 1,054 patients are diagnosed worldwide, and around 115 live in the USA. Of those with congenital FXIII deficiency, approximately 95% of these patients have a deficiency of the A-subunit.