2024-01-19 11:14:20
Lachen, Switzerland (OTS) – Octapharma will present clinical and scientific data that advance our understanding and ours at the 17th Annual Congress of the European Association for Haemophilia and Allied Disorders (EAHAD), taking place February 6-9, 2024 in Frankfurt Advancing treatment of bleeding disorders.
Presentation of Wilate® at EAHAD 2024
Octapharma presents new clinical and scientific findings on Wilate® and Nuwiq®New findings on Von Willebrand syndrome (VWD) and hemophilia A will be presented by leading experts in a satellite symposium, as well as one oral and six poster presentations. Presentations will include new efficacy data and Safety of Wilate® Prophylaxis in People With Von Willebrand Syndrome (VWD)
WIL-31 is the largest prospective prophylaxis study in VWD with an on-demand run-in study as an intra-patient comparison study. The study shows that Wilate® prophylaxis is highly effective in reducing bleeding rates in children and adults with all types of VWD and at all bleeding sites examined. The results provide compelling evidence for the use of regular prophylaxis in people with VWD.
“The new data from the WIL-31 study provide compelling evidence for the use of Wilate® prophylaxis in people with all types of VWD. The results have led to the approval of Wilate® as prophylaxis in the USA, expanding the therapeutic options for these patients” – Larisa Belyanskaya, senior vice president and head of IBU Hematology.
The results of the WIL-31 study will be presented at the Octapharma satellite symposium “Paradigm shift in prophylaxis for VWD: The WIL-31 study in focus”:
Jan Astermark (Sweden) will examine the underuse of prophylaxis in VWD compared to hemophilia A. Robert F. Sidonio Jr. (US) will discuss how the results of WIL-31 have challenged the status quo of prophylaxis in VWD. The effectiveness of the Wilate® prophylaxis is studied in three interactive cases of patients in the WIL-31 study: – Child with VWD, presented by Robert F. Sidonio Jr. from Atlanta – Adult with frequent nosebleeds, presented by Ana Boban from Zagreb – Woman with heavy menstrual bleeding, presented by Csongor Kiss from Debrecen
The satellite symposium will take place on Wednesday, February 7th, from 5:30 p.m. to 6:45 p.m. (CET) in Panorama Hall 2.
The importance of preventing frequent nosebleeds in people with VWD and the effectiveness of Wilate® prophylaxis in this context is discussed by Ana Boban in the oral SLAM presentation “Regular prophylaxis with a plasma-derived von Willebrand factor/factor VIII concentrate is effective in reducing nosebleeds in children and adults with Von Willebrand syndrome” (OR04) on Friday, February 9, 08:30-10:00 CET, Session 6 SLAM.
Two poster presentations provide additional insights into the results of the WIL-31 study:
PO213: No accumulation of factor VIII and von Willebrand factor during prophylaxis with a plasma-derived von Willebrand factor/factor VIII concentrate during the WIL-31 studyPO194: Management of von Willebrand syndrome with inhibitors during Prophylaxis with a plasma-derived von Willebrand factor/factor VIII concentrate – The WIL-31 study
Presentation of Nuwiq® at EAHAD 2024
In addition to its role in the coagulation cascade, there is emerging evidence that FVIII influences platelet and endothelial cell function. Replacement therapy with recombinant FVIII concentrates (rFVIII) has become a mainstay of treatment for people with hemophilia A; however, it is not known whether there is a difference in how modifications of rFVIII concentrates affect platelet and endothelial cell functionality. Binding of Nuwiq® to activated platelets in vitro was found to be stronger compared to other rFVIII concentrates, while in separate studies Nuwiq® showed greater effects on endothelial cell function compared to other rFVIII concentrates:
PO027: Effects of differential binding of recombinant factor VIII concentrates to platelets on platelet functionalityPO024: Investigation of the role of factor VIII in endothelial cell function
For rare diseases such as hemophilia A, a direct comparison of treatments in a clinical trial is not possible. In such cases, indirect treatment comparisons can be used to compare the effects of different treatments. One such established indirect comparison method is the adjusted indirect comparison (MAIC). MAICs were used to compare the effectiveness of personalized, pharmacokinetic-controlled prophylaxis with Nuwiq® with other treatments:
PO041: Personalized prophylaxis with simoctocog alfa compared to standard prophylaxis with efanesoctocog alfa in hemophilia A, an adjusted indirect comparisonPO042: Personalized prophylaxis with simoctocog alfa compared to standard prophylaxis with emicizumab in hemophilia A, an adjusted indirect comparison
“Octapharma’s ongoing commitment to improving patients’ lives is at the core of our values. Supporting clinical and scientific research projects is an essential part of our commitment, and we look forward to presenting the results of this research at EAHAD 2024″ – Olaf Walter, Board Member and Head of International Business Units at Octapharma.
Information regarding Octapharma
Octapharma, headquartered in Lachen, Switzerland, is one of the largest human protein manufacturers in the world and develops and produces human proteins from human plasma and human cell lines.
Octapharma employs more than 11,000 people worldwide, supporting the treatment of patients in 118 countries with products across three therapeutic areas: immunotherapy, hematology and critical care.
Octapharma has seven R&D locations and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden and operates more than 190 plasma donation centers in Europe and the USA. Octapharma has 40 years of experience in patient care.
Information regarding Nuwiq ®
Nuwiq® (Simoctocog alfa) is a 4th generation recombinant factor VIII protein (rFVIII) produced in a human cell line without chemical modification or fusion with another protein 1. It is cultured without additives of human or animal origin, contains no antigenic non-human protein epitopes and has a high affinity for von Willebrand factor1. Nuwiq® treatment was studied in nine 1-3 completed clinical trials involving 201 previously treated patients (190 people)1 and 108 previously untreated patients 2 with severe hemophilia A. Nuwiq® is available in 250 IU, 500 IU, 1,000 IU, 1,500 IU, 2,000 IU, 2,500 IU, 3,000 IU and 4,000 IU dosage forms 4. Nuwiq® is indicated for the treatment and prevention of bleeding in patients with hemophilia A (congenital FVIII deficiency) permitted in all age groups 4.
Information regarding Wilate ®
Wilate® is a highly pure human von Willebrand factor/factor VIII (VWF/FVIII) concentrate that undergoes two virus inactivation steps during its production 5. No albumin is added as a stabilizer5. The purification processes result in a 1:1 ratio of VWF to FVIII that is similar to that of normal plasma 5. Wilate® contains a VWF triplet structure and a content of large high molecular weight multimers that is similar to that of normal human plasma 5. Wilate® is available in 500 IU and 1,000 IU dosage forms.6 Wilate® is indicated for the prevention and treatment of bleeding or surgical bleeding in Von Willebrand syndrome (VWD) when desmopressin (DDAVP) alone is ineffective or contraindicated, as well as for Treatment and prevention of bleeding in patients with hemophilia A (congenital factor VIII deficiency)6. The indication for prophylaxis in the US is listed in the updated prescribing information available here: Wilate – Full Prescribing Information (wilateusa.com)
Octapharma’s press releases are intended specifically for the trade press/medical media and not for the consumer press.
credentials
1.Lissitchkov T et al. Ther Adv Hematol 2019; 10:2040620719858471.
2.Liesner RJ et al. Thromb Haemost 2021; 121:1400-8.
3.Octapharma AG; Archivdaten.
4.Nuwiq® Summary of Product Features.
5.Stadler M et al. Biologicals 2006; 34:281-8.
6.Wilate® Summary of Product Features.
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