FDA approves NovoSeven for Glanzmann's Thrombasthenia-Novo Nordisk
The FDA has approved NovoSeven RT (Coagulation Factor VIIa [Recombinant]), from Novo Nordisk, as 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. Glanzmann's Thrombasthenia is a rare genetic bleeding disorder with limited treatment options.
Approval was based on evidence collected from the global Glanzmann's Thrombasthenia Registry (GTR) (218 patients with 1,073 bleeding and surgical events) and the Hemostasis & Thrombosis Research Society Registry (7 patients with 23 bleeding episodes). The data supported the effectiveness and safety of NovoSeven RT (90 mcg/kg) in the treatment of bleeding and for the prevention of bleeding during surgical procedures in patients with GT.
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