Octapharma recently announced the final results from the NuProtect study, which evaluated the immunogenicity of Nuwiq® in previously untreated patients (PUPs) with severe hemophilia A.Nuwiq® is a recombinant factor VIII therapy, is indicated for on-demand treatment and control of bleeding episodes and routine prophylaxis to reduce the frequency of bleeding episodes and perioperative management of bleeding.
NuProtect was a prospective, multinational, open-label, non-controlled phase III study designed to assess the immunogenicity, efficacy, and safety of Nuwiq®. A total of 110 hemophilia A patients were recruited from 38 sites in 17 countries, 105 if which were PUPs. Once treatment with the therapy was initiated, patients were monitored for 100 exposure days or up to five years. According to an Octapharma press release, of the 105 evaluable PUPs, 26.7% (28/105) developed an inhibitor. Of those patients, 16.2% (17/105) developed high-titer inhibitors, while 10.5% (11/105) developed low-titer inhibitors, five of which were transient.
“The NuProtect study showed that there was a low risk of inhibitor development in PUPs starting treatment with Nuwiq®,” commented Dr Ri Liesner, coordinating investigator of the NuProtect study and clinician at Great Ormond Street Hospital for Children in London, UK. “These data indicate Nuwiq® may be an attractive option for people newly diagnosed with severe haemophilia A, who are young children and represent a vulnerable patient subset.”
The final results of the NuProtect study were published online, February 13, 2021, in the journal Thrombosis and Haemostasis.
Source: Octapharma press release dated February 18, 2021