FDA OKs NovoSeven RT for Glanzmann's Thrombasthenia

Megan Brooks

Disclosures

July 08, 2014

The US Food and Drug Administration (FDA) has approved recombinant coagulation factor VIIa (NovoSeven RT, Novo Nordisk) for bleeding episodes and perioperative management in patients with Glanzmann's thrombasthenia (GT) refractory to platelet transfusions, with or without antibodies to platelets, according to the company.

GT is a rare genetic bleeding disorder affecting about 1 in 1 million people worldwide, "with limited treatment options," the company noted in a news release.

Patients with GT may receive platelet transfusions for severe bleeding episodes or when undergoing surgery. However, some patients do not respond well or at all to platelet transfusions.

The FDA approved NovoSeven for the treatment of GT on the basis of evidence from the global GT Registry, including 218 patients with 1073 bleeding and surgical events, and the Hemostasis & Thrombosis Research Society Registry, including 7 patients with 23 bleeding episodes.

The data support the safety and effectiveness of NovoSeven (90 μg/kg) in the treatment of bleeding and for the prevention of bleeding during major and minor surgical procedures in patients with GT, the company said.

The most common and serious adverse effects are blood clots. NovoSeven should be used with caution in patients with an increased risk for blood clots, the company said. Allergic reactions, including serious whole-body allergic reactions, have also been reported. People with factor VII deficiency should be monitored by their healthcare provider for antibodies, which can cause NovoSeven to stop working properly, the company said.

NovoSeven is also is approved in the European Union for the treatment of bleeding episodes in patients with GT.

Full prescribing information is available on the drug's Web site.

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