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U.S. FDA approves Novo Nordisk's drug for rare blood clotting disorder

Started by riky, December 24, 2013, 09:00:21 AM

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riky

U.S. FDA approves Novo Nordisk's drug for rare blood clotting disorder

(Reuters) - The U.S. Food and Drug Administration said on Monday it has approved Novo Nordisk's drug Tretten to prevent bleeding in patients with a rare blood clotting disorder. Patients with congenital Factor XIIIA-subunit deficiency do not make enough of the Factor XIII protein that is important for normal blood clotting, the FDA said. Factor XIII is composed of subunits A and B and Factor XIII deficiency is usually caused by a deficiency of the A subunit. Tretten was studied in 77 patients with the disorder and was effective in preventing bleeding in 90 percent of the patients when given monthly, the FDA said.

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