Note: The following is edited from a press release from Octapharma. Read the full press release in it’s entirety here.
At the recent American Society of Hematology (ASH) Annual Meeting, Octapharma presented interim data from the ongoing phase 3 study, NuProtect. The NuProtect Study examines the immunogenicity, efficacy and safety of treatment with human cell-line derived recombinant FVIII (Nuwiq) in previously untreated patients (PUPs) with severe haemophilia A – those at greatest risk of inhibitor development. The presentation focused on immunogenicity of Nuwiq in 66 haemophilia A patients who have received at least 20 days of treatment in the ongoing NuProtect study, with no previous exposure to FVIII concentrates or other blood products. The cumulative incidence (95% confidence interval) of all inhibitors was 20.8% (10.7–31.0); 12.8% (4.5–21.2) for high-titre inhibitors and 8.4% (1.3–15.6) for low-tire inhibitors. These data were reported as part of a pre-planned interim analysis for the NuProtect study, which plans to ultimately evaluate at least 100 PUPs, making it one of the largest studies with a single FVIII concentrate.