Novo Nordisk gains FDA backing for new NovoSeven RT indication

Danish diabetes care giant Novo Nordisk’s (NOV: N) hemophilia treatment NovoSeven RT (coagulation factor VIIa [recombinant]) has received approval for an additional indication in the USA.

NovoSeven RT has now been cleared by the US Food and Drug Administration for perioperative management and the treatment of bleeding episodes in patients suffering from Glanzmann's thrombasthenia (a rare genetic bleeding disorder) with refractoriness to platelet transfusions (with or without antibodies to platelets). NovoSeven RT is the first recombinant treatment to gain FDA approval for this indication. NovoSeven RT is already approved for Glanzmann's thrombasthenia in the European Union.

Clinical backing for NovoSeven USA approval