Date: 2013-05-17
Type of information:
phase: 3
Announcement: completion of the trial
Company: Novo Nordisk (Denmark)
Product: N9-GP (glycopegylated recombinant factor IX)
Action mechanism: N9-GP is a long-acting FIX derivative.
Disease: hemophilia B
Therapeutic area: Genetic diseases- Hematological diseases
Country:
Trial
details: The paradigm™ programme is a Novo Nordisk registered trademark for trial conducted with N9-GP. The programme currently comprises seven clinical trials investigating pharmacokinetics, immunogenicity, efficacy and safety of N9-GP in adult and paediatric haemophilia B patients as well as in patients undergoing surgery.
Latest
news: * On May 17, 2013, Novo Nordisk has announced the completion of paradigm™ 2, the first phase 3 trial with a long-acting FIX derivative, N9-GP (glycopegylated recombinant factor IX), for haemophilia B patients. Paradigm™ 2 is a multi-centre, blinded trial evaluating the safety and efficacy of N9-GP when used for on-demand or prophylactic treatment in patients with haemophilia B. In the trial, 74 patients were treated for six months on-demand, or 12 months by a prophylactic regimen of 40 U/kg or 10 U/kg N9-GP once weekly. The median bleeding rate for patients treated on-demand was 15.6 episodes per year. Patients on prophylaxis had a median annualised bleeding rate of 1.0 and 2.9 episodes per year, when treated with weekly doses of 40 U/kg and 10 U/kg, respectively. Among patients randomised to receive 40 U/kg N9-GP, 99% of bleeding episodes were treated with only one infusion, and two-thirds of the patients experienced complete resolution of bleeding in their target joints. Patients in this dose group also reported an improvement in quality of life during the trial. Pharmacokinetic data documented a steady state half-life of 110 hours. In the trial, N9-GP appeared to have a safe and well-tolerated profile. No patients in the trial developed inhibitors, and no apparent differences between the treatment groups were observed with respect to adverse events and standard safety parameters.Novo Nordisk is expecting the two remaining phase 3 trials in the paradigm™ programme involving paediatric patients and patients undergoing surgery respectively to be completed within the next 12 months. Regulatory submission of N9-GP in all major markets is expected in 2015 to enable validation of the commercial scale production.
