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July 7, 2014
13:36 EDTNVONovo Nordisk says FDA approves NovoSeven RT for treatment of GT
Novo Nordisk announced the FDA has approved NovoSeven RT as the first recombinant treatment for bleeding episodes and perioperative management in patients with Glanzmann's Thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets. Glanzmann's Thrombasthenia is a rare genetic bleeding disorder with limited treatment options. The safety and effectiveness of NovoSeven RT were demonstrated in the treatment of severe bleeding episodes and the perioperative management for major and minor surgical procedures for this specific patient population. The FDA approved NovoSeven RT for the treatment of GT based upon evidence collected from the global Glanzmann's Thrombasthenia Registry and the Hemostasis & Thrombosis Research Society Registry The data supported the effectiveness and safety of NovoSeven RT in the treatment of bleeding and for the prevention of bleeding during surgical procedures in patients with GT.
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