NovoEight
At the International Society on Thrombosis and Haemostasis (ISTH) 2015 Congress, Novo Nordisk announced the latest interim data from the guardian2 extension trial for NovoEight (turoctocog alfa), which showed that in a phase 3 trial, long-term efficacy and safety in the prophylaxis and treatment of bleeds was achieved in people with severe haemophilia A.
The pivotal guardian clinical programme was one of the largest and most comprehensive preregistration clinical trial programmes in haemophilia A, with more than 210 patients with severe haemophilia A treated. Interim data collected through 31 December 2013 from 451.6 patient-years on NovoEight show results consistent with previous reports:
• The overall estimated median annual bleeding rate (ABR) achieved during the preventive regimen with NovoEight was 1.56.
• During the preventive regimen, 90% of all bleeding episodes were successfully treated with one or two infusions of NovoEight.
“These interim results provide an extension to the body of evidence supporting the long-term use of NovoEight,” said Dr. Margareth Ozelo, IHTC Hemocentro Unicamp, University of Campinas, Campinas, Sao Paulo, Brazil, and guardian2 investigator. “For people with haemophilia A, finding treatments that are effective at preventing bleeding episodes long-term is essential.”
Guardian2 is a large, multinational extension trial of NovoEight in previously treated patients with haemophilia A from 19 countries who had been enrolled in the pivotal guardian1 and guardian3 trials. Patients received NovoEight in a prophylactic regimen and to treat breakthrough bleeds.
These findings now comprise more than four years of data and more than 450 patient years. No inhibitors to factor VIII were detected and no safety issues were identified, supporting the findings from guardian1 and 3, demonstrating no confirmed inhibitor development in 213 previously treated patients. The most common adverse reactions seen in the study were injection-site reactions, increased hepatic enzymes and fever.