NovoSeven RT Gains Expanded Indication

Novo Nordisk announced that the FDA has approved NovoSeven RT (coagulation factor VIIa [recombinant]), the first recombinant treatment for bleeding episodes and perioperative management in patients with Glanzmann’s Thrombasthenia (GT) with refractoriness to platelet transfusions, with or without antibodies to platelets.

The approval is based on data collected from the global Glanzmann’s Thrombasthenia Registry and the Hemostasis & Thrombosis Research Society Registry on 92 patients treated with NovoSeven RT for 266 severe bleeding episodes and 160 surgical and other invasive procedures. NovoSeven RT treatment was successful in 94.4% of bleeding episodes and 99.4% of surgical procedures.

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NovoSeven RT is currently approved for the treatment of bleeding and for surgical prophylaxis in Hemophilia A and B with inhibitors to Factors VIII and IX, in acquired hemophilia, and in congenital FVII deficiency. It is available in 1mg, 2mg, 5mg, and 8mg vials.

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