OCTAPHARMA
19.10.2020 17:31:13 CEST | Business Wire | Press release
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
Murata’s Releases Technology Guide to Enhance Power Stability in AI-driven Data Centers4.2.2026 03:00:00 CET | Press release
Murata Manufacturing Co., Ltd. (TOKYO: 6981) (ISIN: JP3914400001) has launched a new technology guide entitled: ‘Optimizing Power Delivery Networks for AI Servers in Next-Generation Data Centers.’ Available on the company’s website, the guide introduces specific power delivery network optimization solutions for AI servers that enhance power stability and reduce power losses across the data center infrastructure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203101664/en/ [Murata Manufacturing Co., Ltd.] Technology guide to enhance power stability in AI-driven data centers The guide addresses the rapid advancement and adoption of AI, a trend driving the continuous rollout of new data centers worldwide. As the industry moves toward higher voltage operations and increased equipment density, the resulting increase in overall power consumption has made stable power delivery a critical business issue for data center operators.
The Global Photonics Community Converges in San Francisco as More Than 23,000 Register for Photonics West 20263.2.2026 22:14:00 CET | Press release
The largest annual optics and photonics event highlighted the industry’s best and brightest during a week full of innovation, networking, and research sharing SPIE, the international society for optics and photonics, brought the global optics and photonics community to San Francisco, California, for another successful and enlivening Photonics West. With more than 23,000 registrants, the annual conference and exhibition connected attendees from 40 countries, showcasing the transnational and collaborative spirit of the interdisciplinary industry. The dynamic event ran from 17 to 22 January, with 4,200 technical presentations across 100 conferences, 4 stages of industry-focused panels and presentations, 49 courses, and approximately 1,600 exhibitors in the five expos: Photonics West, BiOS, Quantum West, AR | VR | MR, plus, in its inaugural year, Vision Tech. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203925940/en/ Attend
Vena To Acquire Acterys, Creating a New Category of Enterprise Performance Management: Orchestrated Planning3.2.2026 17:00:00 CET | Press release
The acquisition unites finance foresight and IT innovation in the first Microsoft-native Orchestrated Planning environment, helping enterprises plan better and achieve more by turning strategy into aligned execution in real time. Vena, the only complete FP&A platform powered by agentic AI and purpose-built to amplify the Microsoft technology ecosystem, today announced it has entered into a definitive agreement to acquire Managility Pty Ltd, operating as Acterys (“Acterys”), the industry’s leading Power BI–based operational planning and app development platform, subject to customary closing conditions and regulatory approval. This acquisition unlocks a category-defining way for enterprises to combine planning, analytics, and application development within the Microsoft tools they already trust to run their business. By combining Vena’s Excel-native financial planning and analysis (FP&A) capabilities with Acterys’ proprietary Power BI write-back engine and unified analytics within Micros
Volante Technologies named a Leader in Gartner® Magic Quadrant™ for Banking Payment Hub Platforms3.2.2026 16:15:00 CET | Press release
Volante believes its solutions provide complete always-on payment processing support for banks and financial institutions across all tiers Volante Technologies, the global leader in Payments as a Service (PaaS), today announced its recognition as a Leader in the 2026 Gartner® Magic Quadrant™ for Banking Payment Hub Platforms, which evaluates vendors based on Ability to Execute and Completeness of Vision. In Volante’s view, Gartner positioned them as a Leader based on their capacity to support enterprise-scale payment processing in banks and financial institutions across multiple regions, deployment models, and operational environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260203149834/en/ This graphic was published by Gartner, Inc. as part of a larger research document and should be evaluated in the context of the entire document. As the highest positioned provider in Ability to Execute, Volante believes its AI-pow
Toptal Ranked #1 Most Reliable Professional Services Company in America by Newsweek3.2.2026 16:00:00 CET | Press release
Toptal, the world’s largest fully remote workforce, has been ranked the #1 most reliable professional services company in America on the America’s Most Reliable Companies 2026 list by Newsweek and Statista. The list ranks top US companies based on trust, dependability, and consistent performance in their industry. In Newsweek’s ranking of 300 companies across all industries, Toptal took 10th place, right behind Bank of America and Oracle, which tied for 9th. As the most reliable professional services organization in America, Toptal, which ranked 11th in absolute rankings across all companies, placed well ahead of companies like Accenture (33), Deloitte (39), and Cognizant (66). The America’s Most Reliable Companies 2026 ranking is based on an independent survey of more than 80,000 evaluations submitted by 2,400 business decision-makers at America’s largest companies, including Apple, Dropbox, Johnson & Johnson, and UPS, making this recognition an especially meaningful indicator of prod
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