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FDA approves NovoSeven RT for Glanzmann’s Thrombasthenia
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The FDA recently approved coagulation Factor VIIa recombinant for bleeding episodes and perioperative management in patients with Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, according to a press release issued by its manufacturer.
The safety and effectiveness of coagulation Factor VIIa recombinant (NovoSeven RT, Novo Norodisk) were demonstrated in the treatment of severe bleeding episodes and the perioperative management for major and minor surgical procedures for this specific patient population.
“Novo Nordisk is proud to build on our strong heritage of pioneering new therapies and indications for the bleeding disorders community by offering the only recombinant treatment for Glanzmann’s thrombasthenia,” Eddie Williams, senior vice president of biopharmaceuticals at Novo Nordisk, said in the release. “We're committed to keeping patients at the forefront of all we do, and this approval allows us to expand on this commitment.”
The FDA based its approval in part on evidence collected from two registries. Data from the global Glanzmann’s Thrombasthenia Registry included 218 patients with 1,073 bleeding and surgical events, and data from the Hemostasis & Thrombosis Research Society Registry encompassed seven patients with 23 bleeding episodes.
The data supported the effectiveness and safety of coagulation Factor VIIa recombinant (90 mcg/kg) for the treatment of bleeding and for the prevention of bleeding during surgical procedures in patients with Glanzmann’s thrombasthenia.
The Glanzmann’s Thrombasthenia Registry collected data from 92 patients treated with coagulation Factor VIIa recombinant for 266 severe bleeding episodes, plus data from 77 patients treated with the agent for a combined 160 surgical and other invasive procedures.
A review by independent hematology experts showed treatment was successful in 94.4% of bleeding episodes and 99.4% of surgical procedures.
The most common adverse reactions reported among patients treated for bleeding episodes, surgeries or traumatic injuries were deep vein thrombosis, headache, fever, nausea and dyspnea.
Coagulation Factor VIIa recombinant also is approved in the European Union for the treatment of bleeding episodes in patients with Glanzmann’s thrombasthenia.