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Novo Nordisk A/S Reports Positive Results from First Phase 3 Trial with Long-Acting Factor IX for Treatment of Haemophilia B


Friday, 17 May 2013 08:08am EDT 

Novo Nordisk A/S announced that Company has reported positive results from first phase 3 trial with long-acting factor IX for treatment of 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 annualized 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 randomized 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. Regulatory submission of N9-GP in all major markets is expected in 2015 to enable validation of the commercial scale production. 

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