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
Cegid Acquires Shine to Accelerate the Path of Becoming Europe's Leading Financial Copilot for SMBs and Accountants26.11.2025 15:00:00 EET | Press release
Cegid, a European leader in cloud software for finance, accounting, HR, and retail software, and Shine, a fast-growing European fintech unicorn providing digital business accounts and payments, e-invoicing, accounting, and payroll software to small businesses across Europe, announced today that the companies have entered a definitive agreement to join forces to form a European champion and become a leading provider of software for businesses and their accountants. This transformational combination will create the first fully integrated, cloud-native and AI-driven financial hub for SMBs and accounting professionals in Europe – bringing together market-leading capabilities in e-invoicing, accounting, digital business accounts and payments, tax, HR, and payroll in a single unified platform. Accelerating Cegid’s European growth strategy by serving more than one million SMBs, and 15,000 accountants Shine brings to Cegid more than 400,000 SMB customers, a strong brand, and a highly scalable
U.S. FDA Grants Priority Review to Sonrotoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma26.11.2025 13:00:00 EET | Press release
BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a New Drug Application (NDA) for sonrotoclax, a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor. “Sonrotoclax is advancing with remarkable speed, from Breakthrough Therapy Designation to Priority Review, all within a short window,” said Lai Wang, Ph.D., Global Head of R&D at BeOne. “That pace reflects both the strength of the data and the urgency of the need for patients with R/R MCL. With rapid, deep, and durable responses and a manageable safety profile, sonrotoclax is emerging as a potential best-in-class BCL2 inhibitor, alongside our two other transformative hematology assets – BTK inhibitor BRUKINSA, and investigational BTK degrader BGB-16
Modon Holding Announces a Strategic Investment in Wellington Lifestyle Partners, Expanding Its Global Portfolio in Luxury Lifestyle Destination Development26.11.2025 12:15:00 EET | Press release
Abu Dhabi-based Modon Holding P.S.C (“Modon”) today announced a strategic investment in Wellington Lifestyle Partners (“WLP”), joining a consortium of existing investors in the company. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251125937208/en/ Aerial shot of Wellington International (Photo: AETOSWire) Modon’s investment will support the long-term development of Wellington International equestrian showgrounds and deliver a landmark ultra-luxury real estate development featuring high-end residences, a boutique hotel, a commercial marketplace and a championship golf course located in Wellington, Florida – a global icon of equestrian sport. This investment marks Modon’s first direct investment in an equestrian led development in the United States, complementing its existing global portfolio, and reinforcing its strategy to partner with leading international organisations in expanding its presence across ultra-luxury destin
Epassi Announces Leadership Transition26.11.2025 12:00:00 EET | Press release
Epassi Group, a European leader in digital employee benefits technology, today announced that Nickyl Raithatha will join as Chief Executive Officer. Nickyl will assume the role in 2026. Pekka Rantala, who has served as CEO since September 2019, will remain on the Board as Non-Executive Chair. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251126015983/en/ Pekka Rantala and Nickyl Raithatha Over the past six years, Epassi Group has evolved from a Nordic success story into one of Europe’s leading SaaS employee benefits and wellbeing platforms. The company has expanded both its geographic footprint as well as its product portfolio, driven by a powerful combination of strong organic growth and strategic acquisitions, with backing from TA Associates and Warburg Pincus. Today it has a presence in ten countries and a team of 1,000 people. With net revenue expected to exceed €200 million in 2025, Epassi is redefining employee engage
Enerin raises €15 million Series A to industrialise modular high-temperature heat pumps for global industry26.11.2025 11:00:00 EET | Press release
Enerin, a technology leader in high-temperature heat pumps, has raised €15 million (NOK 180 million) in a Series A led by Climentum Capital, The Footprint Firm, Johnson Controls and Move Energy, with participation from PSV Hafnium and Momentum. “This investment marks our shift from pioneering to full industrialisation, bringing proven high-temperature technology from Norway to industries worldwide,” said Arne Høeg, Founder and CEO of Enerin. “Industrial companies are ready to decarbonise high-temperature heat, but the mass market has lacked simple, profitable solutions that fit everyday operations.” Replacing fossil-fuelled industrial boilers — responsible for nearly 20% of global CO₂ emissions — remains one of the toughest challenges in the energy transition, largely because conventional heat pumps can’t cope with the sector’s highly variable process conditions and high temperatures. Enerin’s modular, flexible and standardised system removes such barriers by adapting automatically to
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