LACHEN, Switzerland, Feb. 22, 2021 / PRNewswire / – Octapharma announced today that the final results of the NuProtect immunogenicity study were obtained from Nuwiqin previously untreated patients (PUPs) with severe hemophilia A in the leading rzteblattThrombosis and Haemostasis(Liesner RJ et al. Simoctocog Alfa (Nuwiq) in Previously Untreated Patients with Severe Haemophilia A: Final Results of the NuProtect Study”https://www.thieme-connect.com/products/ejournals/abstract/10.1055/s-0040-1722623) verffentlicht.
The NuProtect study (NCT01712438; EudraCT 2012-002554-23) is a prospective, multinational, uncontrolled, open-label phase III study that was launched in March 2013 to evaluate the immunogenicity, efficacy and safety of Nuwiqwas initiated. For the study, patients of all ages and ethnicities at 38 locations and in 17 countries were recruited and the patients for one Duration of observed for up to 100 days or up to 5 years. With the enrollment of 110 patients, the NuProtect study is the largest clinical study to test a single product on actually untreated patients.
Among the 105 evaluable PUPs with severe hemophilia A that Nuwiqfor the prevention and treatment of bleeding, the following data are available:
- 16.2% (17/105) of the patients developed high-titer inhibitors
- 10.5% (11/105) of the patients developed high-titer inhibitors, five of them were transient
- 26.7% (28/105) of the patients developed inhibitors of any kind
The NuProtect study showed that there was a lower risk of developing inhibitors in PUPs who received treatment with Nuwiqbegan, “comments Dr. Ri Liesner, Coordinating Investigator the NuProtect study und Kliniker am Great Ormond Street Hospital for Children in London (GB).
The se data show that Nuwiqcould be an interesting treatment option for infants with severe hemophilia A, who are a vulnerable patient subgroup.”
The development of inhibitors to blood coagulation factor VIII (FVIII) is a matter of concern for doctors, patients and their families, especially at the start of treatment. Inhibitory antibodies make FVIII therapy impossible and limit treatment options.
The se data expand the broad spectrum of clinical experiences with hemophilia A patients whom Nuwiqgiven to treat and prevent bleeding.
Nuwiqwas developed in a human cell line for the purpose of minimizing the risk of inhibitors in PUPs “,so Larisa Belyanskaya, Head of Octapharma’s IBU Haematology. We are excited to present this promising data and we hope that it will help to address this important medical challenge. “
We know that patients with hemophilia A have to deal with treatment decisions for a lifetime“, so Olaf Walter, Member of the Board of Directors at Octapharma. This data underscores the potential of Nuwiqto give new confidence to PUPs and their families as they begin their treatment. This publication brings us closer to Octapharma’s mission to bring healthy lives to all patients.”
Earlier this year, the FDA approved the inclusion of immunogenicity data from the NuProtect study in NuwiqPrescribing information. Further publications on other analyzes from the NuProtect study are already planned.
Professor Anthony Chan, Co-author of the publication and Professor of Pediatrics at the McMaster University, Canada, declared: I congratulate and thank Octapharma for developing Nuwiq, sponsoring the study, and providing an excellent form of therapy for patients with hemophilia A.“
Octapharma would also like to thank all participating medical centers as well as patients and their caregivers for their contributions to the study.
Nuwiq(Simoctocog alfa) is a 4th generation recombinant factor VIII protein (rFVIII) that is produced in a human cell line without chemical modification or fusion with another protein.1It is cultivated without additives of human or animal origin and antigenic non-human protein epitopes and has a high affinity for the Von Willebrand factor.1Treatment with Nuwiqwas investigated in seven completed clinical studies in 201 previously treated patients (PTPs, 190 people) with severe hemophilia A, including 59 children.1Nuwiqis available in dosage forms with 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU and 4000 IU.2Nuwiqis approved for the treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency) in all age groups.2
The r Adv Hematol2019; 10:2040620719858471.
2. NuwiqSummary of Product Characteristics.
ber Hmophilie A
Hemophilia A is an x-linked hereditary bleeding disorder caused by a deficiency of factor VIII (FVIII) which, if left untreated, leads to bleeding in muscles and joints and consequently to arthropathy and severe morbidity. This disease affects around 1 in 10,000 men worldwide. Prophylactic FVIII replacement therapy reduces the frequency of bleeding and the risk of permanent joint damage.
Octapharma, based in Lachen (Switzerland), is one of the world’s largest manufacturers of human proteins, which are developed and produced from human plasma and human cell lines.
Octapharma employs more than 9,000 people worldwide to support the treatment of patients in 118 countries with drugs from three therapeutic areas: hmatology, immunotherapy and intensive care.
Octapharma has seven research and development facilities and six state-of-the-art production facilities in Austria, France, Germany, Mexico and Sweden and operates more than 160 blood donation centers across Europe and the USA.
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Octapharma Final results NuProtect study immunogenicity Nuwiq previously untreated patients severe hemophilia published message