FDA Approves Treatment for Clotting Disorder

The Food and Drug Administration on Monday said it had approved Novo Nordisk A/S's (NVO, NOVO-B.KO) Tretten to treat a rare blood-clotting disorder.

It is the first recombinant product for use in the routine prevention of bleeding in adults and children who have the rare disorder, which is known as congenital Factor XIII A-subunit deficiency, the FDA said.

People with the disorder do not produce enough of a protein, Factor XIII, that is important for normal blood clotting, according to the FDA.

"Without treatment, people with this rare condition are at risk for serious and life-threatening bleeding," said Karen Midthun, director of the FDA's Center for Biologics Evaluation and Research.

Tretten, which is distributed by Novo Nordisk Inc., USA, had received orphan-drug designation for this use by the FDA since it is intended for treatment of a rare condition.

American depositary shares of Novo Nordisk were down 58 cents at $179.44. The stock is up 9.9% so far this year.

Write to Michael Calia at [e-mail]

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