Octapharma announces FDA approval of updated NUWIQ® Prescribing Information to include immunogenicity data in previously untreated patients
Octapharma is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved an updated Prescribing Information (PI) for NUWIQ®, Octapharma’s human cell line-derived recombinant factor VIII (FVIII). NUWIQ ® is approved for the prevention and treatment of bleeding in people with haemophilia A. The updated PI includes immunogenicity data from the NuProtect study in previously untreated patients (PUPs).
FVIII inhibitor development is the most serious treatment complication in previously untreated patients (PUPs) with severe haemophilia A. The development of inhibitors against exogenous FVIII can reduce the effectiveness of treatment and negatively impact a patient's long-term joint health and quality of life. Minimising the risk of inhibitor development is therefore a key consideration in treatment decisions for PUPs.
The updated NUWIQ® PI includes data from the NuProtect study, which was the largest prospective study of a single FVIII product in true PUPs. Patients received NUWIQ® for prophylaxis or on-demand treatment and were followed for 100 exposure days or 5 years. Of the 105 PUPs assessed for inhibitor development, 17 (16.2%) developed high-titre inhibitors and 11 (10.5%) developed low-titre inhibitors, 5 of whom had transient inhibitors. Of the 28 patients who developed an inhibitor, 25 did so within 20 days of treatment exposure and no patients developed inhibitors after 34 exposure days.
“Minimising inhibitor risk is of huge importance for haemophilia A patients at the start of their treatment journey,” added Olaf Walter, Board Member of Octapharma. “This update reflects our commitment at Octapharma to supporting patients at every stage of this journey and provide treatment options that can improve patients’ lives.”
About Haemophilia A
Haemophilia A is an X-linked hereditary bleeding disorder caused by a deficiency of factor VIII (FVIII) which, if left untreated, may lead to haemorrhages in muscles and joints and consequently to arthropathy and severe morbidity. The disorder affects around one in every 10,000 males worldwide. Prophylaxis with replacement FVIII therapy reduces the number of bleeding episodes and the risk of permanent joint damage.
About Nuwiq®
Nuwiq® (simoctocog alfa) is a 4th generation recombinant factor VIII (rFVIII) protein, produced in a human cell line without chemical modification or fusion with any other protein1. It is cultured without additives of human or animal origin, is devoid of antigenic non-human protein epitopes and has a high affinity for von Willebrand factor1. Nuwiq® treatment has been assessed in seven completed clinical trials which included 201 previously treated patients (190 individuals) with severe haemophilia A, including 59 children1. Nuwiq® is available in 250 IU, 500 IU, 1000 IU, 2000 IU, 2500 IU, 3000 IU and 4000 IU presentations, all with a 2.5 mL infusion volume2. Nuwiq® is approved for use in the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital FVIII deficiency) across all age groups2.
1. Lissitchkov T et al. Ther Adv Hematol 2019; doi: 10.1177/2040620719858471.
2. Nuwiq® Summary of Product Characteristics.
About Octapharma
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. Octapharma employs more than 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Haematology, Immunotherapy, and Critical Care.
Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, with a combined capacity of approximately 8 million litres of plasma per annum. In addition, Octapharma operates more than 140 plasma donation centres across Europe and the US.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201019005637/en/
Contact information
Macarena Guillamón
corporatecommunications@octapharma.com
+41 (0)55 451 21 21
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Hanseo University Expands Aviation Training Program with New Frasca Flight Training Device10.12.2025 17:05:00 EET | Press release
Frasca International, Inc., a FlightSafety International company and leader in flight simulation, today announced that Hanseo University in South Korea is expanding its aviation program with a new Level 5 Cessna 172 Flight Training Device (FTD), the seventh Frasca device to join the university’s fleet. Hanseo University’s school of Aeronautical Science recognized by the Korean University Accreditation Institute as the nation’s first Specialized University for Training Professional Workforce Industries, continues to expand its state-of-the-art simulation capabilities with the acquisition of a Level 5 Cessna 172 FTD. The addition builds on a partnership with Frasca that has spanned more than two decades and further advances aviation education across Asia. “We were seeking simulators that provided both realism and reliability, and Frasca stood out immediately,” said Dr. HanSuk Jung, Vice President Aeronautics, Hanseo University. “Over the years, our partnership has become a deep and lasti
Bregal Milestone Announces Majority Growth Investment in Beyond Now10.12.2025 17:00:00 EET | Press release
Bregal Milestone, a leading European software growth private equity firm, today announced a majority growth investment in Beyond Now (the “Company”), a fast-growing, cloud-native supply chain software provider for AI-enabled digital commerce. Driven by strong customer demand, Beyond Now has generated profitable growth and >40% last twelve-month ARR growth. Beyond Now supports some of the world’s largest and most innovative Communication Service Providers (CSPs), including Verizon, AT&T, Deutsche Telekom, and NTT, in managing complex digital supply chains to create seamless end-to-end partner and customer operations. Founded in 2018, the Company serves telecommunication providers, technology companies, and private enterprises to efficiently scale and monetize digital services through its suite of modern, Ecosystem Orchestration and Digital Platforms - including an AI Digital Business Platform for orchestrating partner offerings, an AI Digital Marketplace solution for personalized custom
Andersen Global Enhances Legal Capabilities with Addition of Brazilian Member Firm10.12.2025 16:30:00 EET | Press release
Andersen Global reinforces its legal platform in Brazil as Lotti e Araújo becomes a member firm, strengthening the organization’s capabilities in Latin America. Founded over 20 years ago, Lotti e Araújo provides comprehensive legal advisory services to Brazilian and multinational clients across numerous industries. Its multidisciplinary practice includes corporate law, tax, labor, litigation, collection, and credit recovery—along with specialized work identifying hidden assets and recovering appeal and judicial deposits in older cases. The firm also handles arbitration, administrative law, foreign investment, real estate, intellectual property, data protection, and corporate restructuring, and offers paralegal support for company formation and representation before regulatory agencies. The team advises clients on preventive legal strategies and complex disputes before administrative bodies and courts in Brazil. “At Lotti e Araújo, we have built our practice on ethics, precision, and a
NetJets to Bring Starlink High-Speed Connectivity to Fleet10.12.2025 16:05:00 EET | Press release
NetJets, the global leader in private aviation, and Starlink have entered into an agreement to bring high-speed in-flight connectivity to 600 aircraft across NetJets’ global fleet by the end of 2026, unlocking a new level of productivity and exceptional travel experiences in the air. “This agreement with Starlink positions NetJets to continue delivering exceptional travel experiences for our Owners and their guests,” said Patrick Gallagher, President, NetJets Aviation. “With Starlink, travel is elevated with reliable connectivity whether our Owners are flying for business or leisure—as seamless connectivity is critical to the experience our Owners need and deserve.” This multi-year, service level agreement paves the way for NetJets to quickly and seamlessly outfit its aircraft across the U.S. and Europe, with installation beginning as early as this month. Starlink is the world's most advanced satellite constellation using a low Earth orbit to deliver broadband internet capable of suppo
Mercator Ocean International Makes AI Ocean Forecasting Operational with GLONET Validated by OceanBench at NeurIPS 202510.12.2025 16:00:00 EET | Press release
At NeurIPS 2025, one of the world’s leading AI conferences, Mercator Ocean unveiled OceanBench, the first open benchmark designed to assess AI Ocean forecasting models. This milestone follows the publication of Mercator Ocean’s AI model GLONET in September. Together, OceanBench and GLONET represent a decisive step toward integrating artificial intelligence into operational ocean forecasting, strengthening Europe’s leadership in trustworthy, AI-driven predictions at global scale. Presented by Anass El Aouni, Oceanographer and machine learning (ML) researcher, and Quentin Gaudel, ML Systems Architect, OceanBench establishes a unified standard to evaluate AI models against fundamental ocean dynamics. GLONET is the first forecasting system to be validated through OceanBench for operational use. Anass El Aouni : “OceanBench provides a transparent standard to evaluate AI-driven ocean forecasts. By comparing artificial intelligence with physics-based models, we can highlight strengths, identi
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom