LAUGH, Switzerland, 22 February 2021 / PRNewswire / –Octapharma AG today announced the final results of the NuProtect study on Nuwiq immunogenicity® on previously untreated patients (PUP) with severe hemophilia A has been published in leading medical journals Thrombosis and Hemostasis (Liesner RJ et al. “Simoctocog Alfa (Nuwiq®) in a Previously Untreated Patient with Severe Hemophilia A: The End Result of the NuProtect Study ” https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0040-1722623).
The NuProtect Study (NCT01712438; EudraCT 2012-002554-23) is a prospective, multinational, open-label, uncontrolled phase III study initiated in March 2013 to assess the immunogenicity, efficacy and safety of Nuwiq®. The study recruited patients of all ages and ethnicities at 38 locations in 17 countries and followed patients for 100 days or up to 5 years. With a enrollment of 110 patients, the NuProtect study is the largest clinical study to investigate a single product in true PUPs.
Of the 105 PUPs that could be evaluated with severe hemophilia A who received Nuwiq® for prevention and treatment of bleeding:
- 16.2% (17/105) of patients developed high titer inhibitors
- 10.5% (11/105) of patients developed low titer inhibitors, five of which were transient
- 26.7% (28/105) of patients developed any inhibitor
“The NuProtect study shows that there is a low risk of inhibitor development in PUPs starting treatment with Nuwiq®, “comments Dr. Ri Liesner, NuProtect study research coordinator and clinician at Great Ormond Street Hospital for Children at London, England. “This data shows Nuwiq® may be an attractive option for people recently diagnosed with severe hemophilia A, who are children and constitute a subset of susceptible patients.. “
The development of inhibitors into replacement factor VIII (FVIII) is of concern to doctors, as well as for patients and their families, especially when they first start treatment. Inhibitors make FVIII therapy ineffective and limit treatment options.
These data complement the wealth of clinical experience in hemophilia A patients receiving Nuwiq® for the treatment and prevention of bleeding.
“Nuwiq® developed in human cell lines with the aim of minimizing the risk of inhibitors in PUPs,” said Larisa Belyanskaya, Head of Hematology, MOM Octapharma. “We are delighted to share this positive data, which reflects this goal and which we hope will contribute to addressing this major treatment challenge. ”
“We know that hemophilia A patients face life-long treatment decisions, “commented Olaf Walter, Board Member at Octapharma. “This data highlights Nuwiq’s potential® to reassure PUP and their families when they start treatment. This publication brings us closer to Octapharma’s goal of enabling all patients to lead healthy lives. “
Earlier this year the FDA approved the inclusion of immunogenicity data from the NuProtect study at Nuwiq.® Prescribing Information. Further publication of another analysis of the NuProtect study is planned.
Professor Anthony Chan, co-author of the publication and Professor of Paediatrics at McMaster University, Canada, said: “Congratulations and thanks to Octapharma for developing Nuwiq, sponsoring trials and providing excellent therapy for hemophilia A.“
Octapharma would also like to thank all participating centers, as well as their patients and caregivers, for their contributions to this research.
Nuwiq® (simoctocog alpha) is a 4th generation recombinant factor VIII (rFVIII) protein, produced in human cell lines without chemical modification or fusion with other proteins.1. It is cultivated without additives of human or animal origin, without antigenic non-human protein epitopes and has a high affinity for von Willebrand factor.1. Nuwiq® treatment was assessed in seven comprehensive clinical trials that included 201 previously treated patients (PTP; 190 people) with severe hemophilia A, including 59 children.1. Nuwiq® available in 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU and 4000 IU presentations2. Nuwiq® approved for use in the treatment and prophylaxis of bleeding in patients with hemophilia A (congenital FVIII deficiency) in all age groups2.
1. Lissitchkov T et al. There is Adv Hematol 2019; 10: 2040620719858471.
2. Nuwiq® Summary of Product Characteristics.
About Hemophilia A
Hemophilia A is an X-linked hereditary bleeding disorder caused by factor VIII (FVIII) deficiency which, if left untreated, can lead to bleeding in the muscles and joints and consequently to arthropathy and severe morbidity. This disorder affects about one in every 10,000 men worldwide. Prophylaxis with FVIII replacement therapy reduces the number of bleeding episodes and the risk of permanent joint damage.
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein producers in the world, developing and producing human proteins from human plasma and human cell lines.
Octapharma employs more than 9,000 people worldwide to support patient care in 118 countries with products in three therapeutic areas: Hematology, Immunotherapy and Critical Care.
Octapharma has seven R&D locations and six state-of-the-art manufacturing facilities at Austria, France, German, Mexico and Sweden, and operates more than 160 plasma donation centers Europe and United States of America.
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SOURCE Octapharma AG