BLA for Extended Half-Life Factor VIII Hemophilia A Tx Filed With FDA

N8-GP is a glycopegylated form of turoctocog alfa designed for prolonged half-life
N8-GP is a glycopegylated form of turoctocog alfa designed for prolonged half-life

Novo Nordisk announced the submission of a Biologics License Application (BLA) for N8-GP (turoctocog alfa pegol), an extended half-life factor VIII, for the treatment of patients with hemophilia A

The BLA submission was supported by data from the Pathfinder clinical trial program (Pathfinder 2, Pathfinder 3, and Pathfinder 5) which assessed the safety and efficacy of N8-GP for the treatment of bleeds, prophylaxis, and surgery in over 250 children and adults with hemophilia A. 

Data from Pathfinder 2 showed that patients who received N8-GP prophylaxis every 4th day had a median annualized bleeding rate (ABR) of 1.3 episodes vs 30.9 episodes for patients treated on-demand. In Pathfinder 3 (surgery trial), all procedures were effectively performed with N8-GP, and hemostatic response was reported as "excellent" or "good" in almost all of the surgeries (43/45). Moreover, N8-GP was well tolerated and demonstrated a safe profile. In Pathfinder 5, pediatric patients aged 0–11 years experienced a median ABR of 1.95 episodes when N8-GP was given twice weekly for 26 weeks. 

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"Based on the results from the global pathfinder clinical trial program, 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 hemophilia A," said Mads Krogsgaard Thomsen, EVP and CSO, Novo Nordisk. 

For more information call (800) 727-6500 or visit NovoNordisk-US.com.