Novo Nordisk reports positive data from Novoeight phase 3 study in people with haemophilia A
December 8, 2014
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® (Antihemophilic Factor [Recombinant]) 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™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.
"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.
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