The Food and Drug Administration (FDA) has approved updated labeling for Nuwiq® (simoctocog alfa; Octapharma) to include immunogenicity data from the NuProtect study in previously untreated patients with severe hemophilia A.
Nuwiq is a recombinant antihemophilic factor (blood coagulation factor VIII [Factor VIII]) indicated in adults and children with hemophilia A for: on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.
The prospective, multinational, open-label, non-controlled phase 3 NuProtect study assessed the immunogenicity, efficacy and safety of Nuwiq in 105 previously untreated patients with severe hemophilia A. Patients received Nuwiq for prophylaxis or on-demand treatment and were followed for 100 exposure days or up to 5 years.
Findings from the study demonstrated that 16.2% (n=17) of patients developed high titer inhibitors, while 10.5% (n=11) developed low titer inhibitors. Among these 28 patients who developed an inhibitor, 25 did so within 20 days of treatment exposure; no patients developed inhibitors after 34 days of exposure.
Additionally, the efficacy of Nuwiq in the prevention of spontaneous bleeding events was rated as “excellent” in all 50 patients receiving continuous prophylaxis. The on-demand treatment was also rated as “excellent” or “good” for 93% of bleeding episodes, and efficacy as surgical prophylaxis was rated as “excellent” or “good” for 95% of 19 rated surgeries.
Nuwiq is supplied in single-use vials containing nominally 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU and 4000 IU of Factor VIII potency.
For more information visit octapharma.com.
- Octapharma announces FDA approval of updated Nuwiq® prescribing information to include immunogenicity data in previously untreated patients. [press release]. Lachen, Switzerland: Octapharma; October 19, 2020.
- Final results from the NuProtect study demonstrating efficacy of Nuwiq® (simoctocog alfa) in previously untreated patients (PUPs) presented at ASH 2019. [press release]. Lachen, Switzerland: Octapharma; October 12, 2019.