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news.The FDA has approved a new indication for NovoSeven, manufactured by Novo Nordisk, making it the first and only recombinant therapy approved for the treatment of acquired hemophilia, a rare and potentially fatal bleeding disorder.
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As a recombinant therapy, NovoSeven is not plasma-derived and poses no risk of human viral transmission through its use. NovoSeven was first introduced in 1999.
The FDA approved NovoSeven for treatment of bleeding episodes in patients with acquired hemophilia, and in the prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia.
“The approval of NovoSeven for use in patients with acquired hemophilia offers an effective choice for treating this life-threatening disorder,” said Craig. Kessler, Professor of Medicine and Pathology, Georgetown University Medical Center.
Acquired hemophilia appears in up to 4 persons per million per year. It disrupts the body's natural blood clotting process, causing spontaneous, uncontrolled bleeding to occur, most often, in the skin and soft tissues.