Novo Nordisk's NovoEight provides safety and efficacy in hemophilia A bleeds

Danish diabetes care giant Novo Nordisk (NOV: N) has announced interim data from the Phase III trial of its already marketed NovoEight (turoctocog alfa) showing it provided long-term efficacy and safety in the prophylaxis and treatment of bleeds in people with severe hemophilia A.

The data from the guardian 2 extension trial is part of the pivotal guardian clinical program, one of the largest and most comprehensive preregistration clinical trial programs in hemophilia A. More than 210 patients with severe hemophilia A have been treated. Interim data collected through December 31 2013 from 451.6 patient years on NovoEight showed results consistent with previous reports.

The overall estimated median annual bleeding rate achieved during the preventative regimen was 1.56, and during the preventative regimen, 90% of all bleeding episodes were successfully treated with one or two infusions of NovoEight.