N8-GP long acting Factor VIII completes Phase III trial for Haemophilia A - Novo Nordisk
Novo Nordisk has announced the completion of pathfinder 2, the first phase III trial with long-acting recombinant factor VIII, N8-GP (turoctocog alfa pegol) for haemophilia A patients.
Pathfinder 2 is a multi-national trial evaluating safety and efficacy of N8-GP, when administered for prophylaxis and on-demand treatment in patients with Haemophilia A, who are 12 years or older. In the trial, 175 patients were treated with a prophylactic regimen of 50 U/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. N8-GP appeared to have a safe profile and to be well tolerated. Among the 186 patients in the trial, one patient who responded well to prophylactic treatment throughout the trial developed an FVIII inhibitor. This is in line with expectations in a population of previously treated Haemophilia A patients.
N8-GP treats Haemophilia A by replacing the key coagulation protein factor VIII, but the new formulation is glycopegylated to extend its half-life and allow for less frequent administration.
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