Nuwiq Demonstrates Low Inhibitor Development Rates In Previously Untreated Patients With Severe Hemophilia A
Lachen, Switzerland – Octapharma has announced that the final results from the NuProtect study on the immunogenicity of Nuwiq® in previously untreated patients (PUPs) with severe hemophilia A have been published in the medical journal Thrombosis and Haemostasis.
Overview Of The NuProtect Study
Initiated in 2013, NuProtect is a prospective, multinational, open-label, non-controlled phase III study designed to assess the immunogenicity, efficacy, and safety of Nuwiq®.
The study enrolled 110 patients across 38 centers in 17 countries, making it one of the largest clinical studies focusing on a single product in PUPs with severe hemophilia A.
Study Results
Among the 105 evaluable patients:
- 16.2% (17 patients) developed high-titer inhibitors.
- 10.5% (11 patients) developed low-titer inhibitors, with 5 cases being transient.
- The overall inhibitor development rate was 26.7% (28 patients). citeturn0search0
Expert Commentary
Dr. Ri Liesner, coordinating investigator of the NuProtect study and a consultant at Great Ormond Street Hospital in London, commented:
“The study shows that the risk of inhibitor development is low in previously untreated patients who start treatment with Nuwiq®.
This is significant for newly diagnosed patients with severe hemophilia A, particularly young children.”
Larisa Belyanskaya, Head of Octapharma’s Hematology International Business Unit, added: “Nuwiq® was developed in a human cell line to reduce the risk of inhibitor development in PUPs.
We are pleased to see these positive data and hope they will help address this critical treatment challenge.”
Regulatory Recognition
Based on the NuProtect study data, the U.S. Food and Drug Administration (FDA) has approved the inclusion of these immunogenicity data in Nuwiq®’s prescribing information, further solidifying its role in the treatment of hemophilia A.
About Nuwiq®
Nuwiq® (simoctocog alfa) is a fourth-generation recombinant factor VIII protein produced in a human cell line without chemical modification or fusion with other proteins.
It is cultured without human or animal-derived additives and exhibits high affinity for von Willebrand factor.
Nuwiq® is approved for the treatment and prophylaxis of bleeding in patients of all ages with hemophilia A.
The results of this study provide new evidence for the use of Nuwiq® in PUPs with severe hemophilia A, demonstrating a low rate of inhibitor development and offering a valuable treatment option for patients and clinicians.
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