Novo Nordisk’s Refixia has come out on top in a head to head study assessing its effect in patients with the bleeding disorder haemophilia B against Swedish Orphan Biovitrum’s recombinant factor IX-Fc fusion protein (rFIXFc).
Adults with haemophilia B are at risk from serious bleeding because they either lack or have malfunctioning factor IX, a protein essential for blood clotting.
In the trial, findings of which were presented at the WFH 2018 World Congress in Glasgow, UK, total factor IX exposure of Refixia (nonacog beta pegol; N9-GP) in patient plasma after injection of a single dose was 4.39-fold greater than for rFIXFc.
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 firm noted.
“As a clinician, I know first-hand how challenging it can be to help people living with haemophilia B reach their treatment goals and be adequately protected from bleeding” said Dr Carmen Escuriola Ettingshausen of the Rhein-Main Haemophilia Centre (HZRM), Germany. “These data will help us better understand the different treatment options and choose the appropriate treatment for each patient.”
Also of note, the half-life of Refixia in the trial was 103.2 hours, significantly longer than the half-life of rFIXFc (84.9 hours), while total factor IX activity levels 30 minutes after infusion were found to be two-fold greater with Refixia compared to rFIXFc.
No patients developed inhibitors and no safety concerns were identified during the trial, Novo stressed.
“These head-to-head data support the strong clinical profile of Refixia which can provide an alternative treatment option for people with haemophilia B with the convenience of a single weekly dose,” noted Mads Krogsgaard Thomsen, Novo’s executive vice president and chief science officer.
Both Alprolix and Refixia are approved for use in Europe to prevent bleeding in haemophilia B patients.