Positive Ph III results with Novo Nordisk’s N8-GP, a long-acting hemophilia A agent

Danish insulin giant Novo Nordisk (NOV: N) says it has completed the pathfinderT2, the first Phase III trial with long-acting recombinant factor VIII, N8-GP (turoctocog alfa pegol) for hemophilia A patients.

PathfinderT2 is a multi-national trial evaluating safety and efficacy of N8-GP, when administered for prophylaxis and on-demand treatment in patients with hemophilia A, who are 12 years or older.

In the trial, 175 patients were treated with a prophylactic regimen of 50U/kg every fourth day and 11 patients received on-demand treatment, when bleedings occurred. Patients were treated for up to 21 months, resulting in median annualised bleeding rates of 1.3 and 30.9 episodes for patients treated prophylactically and on-demand, respectively. The pharmacokinetic data documented a single dose half-life of 18.4 hours and a mean trough level of 8% measured immediately before next dose for patients on prophylaxis treatment.