Refixia achieves greater total factor IX exposure in people with haemophilia B than recombinant factor IX-Fc fusion protein.- Novo Nordisk.

Adults with haemophilia B who received a single dose Refixia (nonacog beta pegol; N9-GP) from Novo Nordisk, achieved greater total factor IX exposure than those treated with rFIXFc (recombinant factor IX-Fc fusion protein). The head-to-head paradigm7 trial also observed a longer half-life for Refixia . These pharmacokinetic findings were presented at the WFH 2018 World Congress in Glasgow, UK.

The trial showed that the total factor IX exposure of Refixia in patient plasma after injection of a single dose (50 IU/kg) was 4.39-fold greater than for rFIXFc, as measured by the area under the curve (AUC). Seven days after injection, the factor IX activity in patients treated with a single dose of Refixia was six-fold greater than that of patients treated with rFIXFc at the same dose. The half-life of Refixia in the trial was 103.2 hours, significantly longer than the half-life of rFIXFc (84.9 hours). In addition, total factor IX activity levels 30 mins after infusion were two-fold greater with Refixia compared to rFIXFc. No patients developed inhibitors and no safety concerns were identified during the trial.