Novo Nordisk has filed regulatory applications in the US and European Union seeking approval to market N8-GP for the treatment of haemophilia A.
N8-GP (turoctocog alfa pegol) is an extended half-life factor VIII therapy which demonstrated clinical efficacy and tolerability in the pathfinder clinical trial programme.
In one trial, adults treated prophylactically with N8-GP every fourth day experienced a median annualised bleeding rate of 1.3 episodes compared to 30.9 episodes for people treated on-demand.
Also, paediatric participants experienced a median annualised bleeding rate of 1.95 episodes when administered twice weekly.
In the surgery trial, “all surgeries were effectively performed with N8-GP, and clinical efficacy evaluated by haemostatic response was reported as ‘excellent’ or ‘good’ in 43 out of the 45 performed surgeries,” the firm noted.
“Based on the results from the global pathfinder clinical trial programme, we believe N8-GP can reduce the burden of treatment by decreasing the number of intravenous infusions while achieving the benefits in terms of efficacy and safety for people with haemophilia A,” said Mads Krogsgaard Thomsen, Novo’s executive vice president and chief science officer.