Analysis of Phase III data for NovoEight in Haemophilia A- Novo Nordisk

Novo Nordisk announced a new analysis of phase III data demonstrating people with Haemophilia A who had the highest annualised bleeding rate (ABR) during initial treatment with NovoEight (turoctocog alfa) showed the largest reduction in bleeding over the duration of treatment. Data for the recombinant factor VIII (rFVIII) product NovoEight were presented at the 56th Annual Meeting of the American Society of Hematology (ASH). The post hoc analysis from the GUARDIAN T2 trial further found that, when continued on treatment with NovoEight, adults and adolescents showed reductions of 69% and 63%, respectively, in ABR compared with their ABRs from GUARDIAN T1. The GUARDIAN T1 trial (along with GUARDIAN T3) showed that NovoEight was efficacious in preventing and reducing bleeds with no confirmed inhibitor development in 213 previously treated patients. "This post hoc analysis gives an indication that patients with high baseline bleed rate can benefit from prophylaxis with NovoEight, as well as patients who maintain low ABR," said Margareth Ozelo, M.D., Ph.D., Hemocentre, IHTC, University of Campinas, Sao Paulo, Brazil, and lead investigator.