Update on Novo Nordisk's clinical trial programme on NovoSeven.

Abstract

Recombinant coagulation factor VIIa (rFVIIa; Novoseven, Novo Nordisk A/S, Bagsvaerd, Denmark) is registered in most regions of the world for the treatment of bleeding episodes in haemophilia patients with inhibitors to factor VIII or IX. Since its initial availability, there have been several case stories on the investigational use of rFVIIa as a haemostatic agent in a variety of bleeding patients. Novo Nordisk recognizes the need to establish clinical guidance, and when possible, regulatory approvals for indications with bleeding episodes of various aetiologies. Currently, the safety and efficacy of rFVIIa is being investigated in 11 multinational, phase II trials, involving more than 1500 patients. Most of these trials have been designed to establish the efficacy of rFVIIa as a rescue treatment in episodes of severe life-threatening (upper gastrointestinal bleeding, stem cell transplantation, intra-cerebral haemorrhage and trauma). The remaining focus is on the prophylactic use of rFVIIa to improve haemostasis during surgery (orthotopic liver transplantation and liver resection), with the aim of avoiding or reducing the need for blood transfusions. In addition, Novo Nordisk is also continuing studies in haemophilia patients with inhibitors to increase therapeutic knowledge within this indication. Studies addressing dosages and regimens in subpopulations are presently ongoing.