NovoEight®, phase 3 data show reduction in annualised bleeding rate over time in people with haemophilia A
Posted: 9 December 2014 |
Novo Nordisk announced a new analysis of phase 3 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…
Today, Novo Nordisk announced a new analysis of phase 3 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).1
The post hoc analysis from the guardian™2 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™1. The guardian™1 trial (along with guardian™3) showed that NovoEight® was efficacious in preventing and reducing bleeds with no confirmed inhibitor development in 213 previously treated patients.2,3
“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.
The most common adverse reactions (≥0.5%) seen in the study were injection site reactions, increased hepatic enzymes, and fever.4
References
- Ozelo M. et al. Changes in annualized bleeding rate over time and relationship with dosing of turoctocog alfa during the guardian™ programme. Poster presentation #2850. 56th Annual Meeting and Exposition of the American Society of Hematology. December 6–9, 2014.
- Lentz SR. et al. Results from a large multinational clinical trial (guardian™1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy. Haemophilia. 2013;19(5):691-697.
- Kulkarni R. et al. Results from a large multinational clinical trial (guardian™3) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics. Haemophilia. 2013;19(5):698-705.
- Novoeight® (Antihemophilic Factor [Recombinant]) Prescribing Information. Plainsboro, NJ: Novo Nordisk Inc.; November 2014.
