OCTAPHARMA
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201019005637/en/
Link:
About Business Wire
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
Nippon Electric Glass to Start World’s First Mass Production of Low-Carbon Pharmaceutical Glass Tubing Using an All-Electric Furnace16.12.2025 03:00:00 CET | Press release
Nippon Electric Glass Co., Ltd. (NEG)(TOKYO:5214), a global leader in specialty glass headquartered in Otsu, Japan, announced it will begin the world’s first mass production of pharmaceutical-grade glass tubing using an all-electric melting furnace. Commercial production is scheduled to start in December 2025 at its subsidiary in Selangor, Malaysia. This breakthrough introduces a new manufacturing model for pharmaceutical packaging. By combining NEG’s proprietary all-electric melting technology with renewable energy, CO2 emissions from glass tubing production can be reduced by up to 90%*1 compared with conventional fossil-fuel combustion furnaces. This positions NEG as a major supplier capable of delivering both high-performance borosilicate glass and a significantly lower carbon footprint, directly addressing global sustainability demands from pharmaceutical companies and regulators. NEG is a leading global supplier of arsenic-free, environmentally friendly borosilicate glass tubing f
Esco Aster Signs Exosome Clinical cGMP Manufacturing Contract With Shine-On Biomedical For A Novel First-In-Class HLA-G Targeting Exosome Drug Delivery Platform16.12.2025 02:00:00 CET | Press release
Esco Aster, a vertically integrated cell and derivatives CRDMO based at JTC LaunchPad Singapore, announced CMC manufacturing support for Shine-On Biomedical’s HLA-G targeted exosome program. Shine-On Biomedical sponsored Esco Aster in 2023 for cGMP services, starting with high-yield exosome development using Esco Aster’s cell line platform. The technical reports of process, analytical, and formulation development, exosome drug loading, GMP engineering runs, and stability studies supported Shine-On’s IND submission. The IND was cleared by the U.S. FDA in Q1 2025. Furthermore, Esco Aster is providing technical services for exploratory exosome loading feasibility studies per Shine-On’s instruction. Shine-On Biomedical is an emerging innovator in exosome-based drug delivery. ShineOn’s proprietary product, SOB100, a HLA-G targeted exosome drug delivery carrier, has passed the U.S. FDA IND review and ongoing Phase I study, making it as a first-in-class–potential HLA-G targeted exosome platfo
Civil Air Patrol Expands Fleet With 15 New Cessna Aircraft to Support Lifesaving and Community Missions15.12.2025 17:00:00 CET | Press release
Latest deliveries bring CAP’s Cessna fleet to more than 500 aircraft nationwide Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, announced today that Civil Air Patrol (CAP), the world’s largest operator of Cessna aircraft, is strengthening its national mission capabilities with an order for 15 additional piston-engine aircraft, including seven Cessna Skyhawk 172 and eight Cessna Skylane 182 models scheduled for delivery throughout 2026. The order follows recent deliveries of an additional two Cessna Skylane and one Cessna Turbo Stationair HD aircraft, expanding CAP’s fleet to more than 500 Cessna aircraft nationwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215613573/en/ Delivery of an additional two Cessna Skylane and one Cessna Turbo Stationair HD aircraft joins CAP’s fleet of more than 500 Cessna aircraft nationwide. Cessna aircraft are designed and produced by Textron Aviation. “Civil Air Patrol’s miss
Winston & Strawn and Taylor Wessing UK to Combine, Creating a Premier Transatlantic Law Firm15.12.2025 16:52:00 CET | Press release
Winston Taylor to build on shared vision and culture in establishing a transatlantic powerhouse for major litigation, critical transactions, strategic IP, and private wealth Winston & Strawn and Taylor Wessing’s UK-led business announced today their intention to combine, creating a premier transatlantic law firm that would operate under a new shared name, Winston Taylor. The combination responds to increasing client demand for seamlessly integrated US–UK–EU counsel for the businesses, people, and markets driving capital and innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215914957/en/ The combination once final will unite two international firms with more than 400 years of combined history, complementary strengths, and a common vision to meet clients’ evolving global needs. The combined firm will include more than 1,400 lawyers, establishing one of the largest transatlantic firms whose footprint is primarily in
Despite Barriers, Financial Institutions are Clear About AI's Greatest Impact15.12.2025 16:32:00 CET | Press release
HTEC Finds AI is Everywhere in FSI, but Scaling Across the Enterprise Remains the Industry's Biggest Hurdle HTEC, a global AI-first provider of software and hardware design and engineering services, today released The State of AI in Financial Services & Insurance 2025, a first industry subset of its global research report in AI. This publication offers one of the clearest views to date into how financial institutions are adopting and scaling artificial intelligence. This industry-focused report analyzes insights from 250 C-suite leaders within financial services and insurance, drawn from HTEC’s broader global study of 1,529 C-suite executives—including CIOs, CTOs, CDOs, CPOs, CFOs, COOs, CEOs and CSOs—across Saudi Arabia, the UAE, the United Kingdom, the United States, Germany and Spain. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251215790717/en/ Executive Summary: The State of AI in Financial Services and Insurance 2025
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