OCTAPHARMA
18.6.2018 09:08:03 CEST | Business Wire | Press release
Octapharma announced today that the European Medicines Agency (EMA) has approved an extension of marketing authorisation for its human cell line-derived recombinant factor VIII (rFVIII) product, Nuwiq® . New single dose vial strengths of 2500, 3000 and 4000 International Units (IU) will be available in Europe, in addition to the current strengths of 250, 500, 1000 and 2000 IU.
The new Nuwiq® vial strengths have been available in the US since September last year, following approval by the FDA. Nuwiq® is indicated in adults and children of all ages for on-demand treatment and prophylaxis, including during surgery, to prevent and control bleeding episodes in patients with haemophilia A.
This expanded array of vial strengths has the potential to increase treatment options for patients with haemophilia A by improving dosing flexibility. Patients who previously required more than one vial per infusion may be able to reduce the number of vials needed. Nuwiq® is the only rFVIII available in an extended range of vial sizes that are reconstituted in a volume of 2.5 mL.
The new vial sizes could be particularly beneficial to patients treated with Nuwiq® based on a pharmacokinetic (PK)-guided personalised prophylaxis approach. The NuPreviq Approach uses each individual’s own PK profile to tailor the treatment plan to the individual patient. In the NuPreviq study, the use of this approach enabled over half (57%) of patients to reduce Nuwiq® dosing to twice weekly or less, whilst maintaining effective bleed protection (median annualised bleeding rate for all bleeds: 0 )1 . During personalised prophylaxis with Nuwiq® , 83% of patients were spontaneous bleed free. A second approach to individualising dosing uses PK analysis of a group of people to predict the optimal treatment for an individual; a Nuwiq® -specific predictive model is available as part of the Web Accessible Population Pharmacokinetics Service - Hemophillia (WAPPS-Hemo). The increase in vial options for Nuwiq® could enable physicians to more closely align to a specific, individualised dosing regimen by combining vial strengths, allowing more flexibility in dosing, and supporting the optimisation and personalisation of haemophilia care.
Larisa Belyanskaya, Head of Octapharma Haematology IBU, said “the increase in vial strength options will benefit patients and physicians by providing further treatment flexibility and convenience with Nuwiq® . As personalised prophylaxis becomes a major part of haemophilia treatment, this flexibility will simplify dosing to facilitate the optimisation of treatment for every individual patient”. Olaf Walter, Board Member of Octapharma, added that “this change represents another mark of Octapharma’s ongoing commitment to improving the lives of the haemophilia community”.
About Nuwiq ®
Nuwiq® is a 4th generation rFVIII protein2 , produced in a human cell line without chemical modification or fusion with any other protein3 . Nuwiq® is cultured without additives of human or animal origin3 , is devoid of antigenic non-human protein epitopes4 and a high affinity for the von Willebrand coagulation factor5 . Nuwiq® treatment has been assessed in seven completed clinical trials which included 201 PTPs6,7 (190 individuals) with severe haemophilia A, including 59 children8 . Nuwiq® is approved for use in the treatment and prophylaxis of bleeding across all age groups of PTPs with haemophilia A in the EU, US, Canada, Australia, Latin America and Russia. Further worldwide submissions for Nuwiq® are planned.
About Haemophilia A
Haemophilia A is an X-linked hereditary disorder caused by FVIII deficiency which, if left untreated, leads to haemorrhages in muscles and joints and consequently to arthropathy and severe morbidity. FVIII replacement prophylactic treatment reduces the number of bleeding episodes and the risk of permanent joint damage. This disorder affects one in every 5,000 to 10,000 men worldwide. Globally, 75% of haemophilia cases are left undiagnosed or untreated. The development of neutralising FVIII antibodies (FVIII inhibitors) against infused FVIII represents the most serious treatment complication. The cumulative risk of FVIII inhibitor development is reported to be currently up to 39%.
About Octapharma
The vision of Octapharma is “Our passion drives us to provide new health solutions advancing human life”. 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. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. Our company values are Ownership, Integrity, Leadership, Sustainability and Entrepreneurship.
In 2017, the Group achieved €1.72 billion in revenue, an operating income of €349 million and invested €287 million to ensure future prosperity. Octapharma employs around 7,700 people worldwide to support the treatment of patients in 113 countries with products across three therapeutic areas:
• Haematology (coagulation disorders)
• Immunotherapy (immune disorders)
• Critical care
Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden.
For more information visit www.octapharma.com
1. Lissitchkov T, et al. Haemophilia 2017;23:697-704.
2. Lieuw K. J Blood Med 2017; 8: 67–73.
3. Casademunt E, et al. Eur J Haematol 2012; 89: 165-76.
4. Kannicht C, et al. Thromb Res. 2013; 131: 78-88.
5. Sandberg H, et al. Thromb Res 2012; 130: 808-17.
6. Valentino LA, et al. Haemophilia 2014; 20(Suppl. 1): 1-9.
7. Lissitchkov T, et al. Haemophilia 2017; 23: 697–704.
8. Klukowska A, et al. Haemophilia 2016; 22, 232-39.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180618005435/en/
Contact:
Octapharma AG
International Business Unit - Haematology
Olaf
Walter
Olaf.Walter@octapharma.com
or
Larisa
Belyanskaya
Larisa.Belyanskaya@octapharma.com
Tel:
+41 55 4512121
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
Registrar Corp Acquires TechniCAL and Becomes the Global Compliance Leader in Shelf-stable Packaged Foods Safety4.2.2026 13:00:00 CET | Press release
Registrar Corp, the world’s largest food and beverage regulatory compliance provider, today announced its acquisition of TechniCAL, the world’s leading independent Process Authority for low-acid and acidified foods. Registrar Corp is a Paine Schwartz Partners portfolio company. Consumer demand for convenience and longer product life without refrigeration has driven rapid growth in shelf-stable foods and beverages, with packaging innovations extending beyond cans and glass jars to formats such as retort pouches and cartons. Ensuring products in these various packaging formats are safe from harmful microorganisms is critical to public health and required by the U.S. FDA. Together, Registrar Corp and TechniCAL provide the industry’s most complete solution, combining proven scientific expertise, regulatory knowledge, training, and advanced thermal testing. “TechniCAL is world renowned for its Process Authority expertise and advanced testing technologies assuring compliant thermal processin
Kinaxis Announces Intention to Maximize Size of Normal Course Issuer Bid4.2.2026 13:00:00 CET | Press release
Kinaxis® Inc. (“Kinaxis” or the “Company”) (TSX: KXS) today announces that it intends to amend its current normal course issuer bid (the “NCIB”) to increase the number of its common shares (the “Shares”) that may be repurchased from 1,403,042, representing 5% of the Company’s issued and outstanding Shares as at October 31, 2025, to approximately 2,799,843, representing 10% of the Company’s “public float” as at October 31, 2025, which is the maximum allowable under the rules of the Toronto Stock Exchange (the “TSX”). The Company has already invested US$54 million under its current NCIB. At the average price paid to date for the Shares under the current NCIB, repurchasing 10% of the Shares would represent an additional investment of approximately US$284 million. “There is a fundamental misunderstanding of the opportunities and threats from generative and agentic AI to mission-critical enterprise software, like ours, that solves deeply complex problems and enables highly consequential dec
Morgan Stanley Inclusive & Sustainable Ventures Hosts Global Demo Day, Opens Applications for Next Cohort4.2.2026 13:00:00 CET | Press release
Morgan Stanley (NYSE: MS) today is hosting its annual global Inclusive & Sustainable Ventures (MSISV) Demo Day, with startups and nonprofits participating from across the Americas, Europe, the Middle East and Africa (EMEA). The organizations will pitch over 300 investors, as well as potential business partners and customers. Over the past five months, MSISV has supported 29 startups and four nonprofits through an intensive accelerator program, providing them with capital, a tailored curriculum, mentorship opportunities and business-growth resources from Morgan Stanley’s ecosystem of internal and external partners. “With founders spanning 10 countries and 13 industries, our Morgan Stanley Inclusive & Sustainable Ventures cohort underscores the potential of innovators globally to bring disruptive solutions for business and society to market,” said Jessica Alsford, Morgan Stanley Chief Sustainability Officer. “We are eager to watch as these founders continue to scale with the backing of o
Macrobond Launches Macrobond Amplify, A New Standard for Interactive Financial Research4.2.2026 13:00:00 CET | Press release
Macrobond, the global platform for macroeconomic and financial data, announced the launch of Macrobond Amplify, a browser-based research distribution tool that enables economists and analysts to deliver rich, interactive content to their consumers at scale. Amplify empowers analysts and research teams to move beyond static charts and PDFs, delivering interactive, explorable insights that build trust, foster collaboration, and drive better decision-making. With Amplify, research teams can publish interactive, auditable research models that clients can explore directly through charts and dynamic visualizations. By sharing a simple link, Amplify users can distribute their research at scale with both internal partners and clients. “As the research industry evolves, analysts and economists face growing pressure to ensure their work reaches the right audiences, shows transparency, and demonstrates the rigour behind their thinking,” says Dan Seal, Chief Product Officer at Macrobond. “Amplify
Tula Technology Builds Global Momentum Expanding OEM and Tier 1 Engagements4.2.2026 08:00:00 CET | Press release
Provides 2026 business outlook with multiple start of production (SOP) targets in 2027 Tula Technology, Inc., a leader in propulsion efficiency and developer of Dynamic Motor Drive® (DMD), today provided a business update highlighting further technical progress across China and Europe as the Company advances towards global commercialization. In the fourth quarter of 2025, another Global Tier 1 completed DMD testing, achieving efficiency exceeding expectations. The Company also signed two additional memoranda of understanding, expanding engagement with OEMs and Tier 1 suppliers. In total, Tula is advancing six development programs towards a start of production (SOP) in 2027, with additional programs to follow. In China, Tula has recently signed two additional agreements – one with a Chinese OEM and another with a global Tier 1 supplier. The OEM has already begun dynamometer testing to confirm the DMD benefit, and upon meeting expectations, an over-the-air update adding DMD software into
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