Positive new Ph III data for Novo Nordisk’s NovoEight in hemophilia A

Danish diabetes major Novo Nordisk (NOV: N) yesterday presented a new analysis of Phase III data demonstrating that people with hemophilia A who had the highest annualized 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, which was approved by the US Food and Drug Administration and European Medicines Agency more than a year ago for the treatment and prophylaxis of bleeding in patients with hemophilia (The Pharma Letter October 10, 2013), were presented at the 56th annual meeting of the American Society of Hematology (ASH).

The post hoc analysis from the guardianT2 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 guardianT1. The guardianT1 trial (along with guardianT3) 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, of Hemocenter, 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.

NovoEight is also approved in Japan (January 2014), Australia (January 2014), and Switzerland (February 2014), and applications for regulatory approvals have been submitted in a range of other countries, the company noted.