OCTAPHARMA
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
MultiBank Group Confirms $MBG Token TGE Set for July 22, 202512.7.2025 11:14:00 CEST | Press release
MultiBank Group, the world’s largest financial derivatives institution has officially announced that the Token Generation Event (TGE) for its highly anticipated $MBG Token will take place on July 22, 2025. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250712404220/en/ MultiBank Group has officially announced that the Token Generation Event (TGE) for its highly anticipated $MBG Token will take place on July 22, 2025. This milestone will mark the full activation of the $MBG Token on the blockchain, enabling holders to view and manage their balances across supported platforms. Following the token minting, users will be able to trade $MBG via MultiBank.io, the Group’s regulated crypto exchange and Uniswap, the world’s leading decentralized platform. The $MBG Token has garnered global attention for its rare combination of real-world utility, institutional backing, and strong deflationary mechanics. It is underpinned by $29 billi
Elegen and Nutcracker Therapeutics to Pilot First Fully Cell-Free Manufacturing Process for RNA-based Personalized Cancer Therapeutics11.7.2025 14:00:00 CEST | Press release
Fully cell-free process aims to further democratize personalized cancer therapeutic manufacturing with shorter turnaround times and negligible bioburden and endotoxin risks. Elegen, a global leader in next-generation DNA manufacturing, and Nutcracker Therapeutics, a global leader in next-generation RNA design and manufacturing, today announced the launch of a pilot program to demonstrate the industry’s first fully synthetic, cell-free manufacturing platform for RNA-based personalized cancer therapeutics (PCTs). The pilot marks another step toward making PCTs more accessible, timely, and scalable. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711152688/en/ As late-stage PCT clinical trials progress and therapy developers work to create the next generation of PCTs, the speed, reliability, scaling and cost of traditional production methods pose a major challenge. Specifically, the first step of DNA template production is hi
$MBG Token Pre-Sale Set for July 15 — Only 7 Million Tokens Available at $0.3511.7.2025 10:17:00 CEST | Press release
MultiBank Group, the world’s largest financial derivatives institution headquartered in Dubai, has confirmed that its highly anticipated $MBG Token pre-sale will go live on July 15, with demand expected to be intense. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711737311/en/ With only 7 million $MBG tokens up for grabs at an exclusive entry price of $0.35, this is a rare opportunity to secure early access to what many are calling the year’s most powerful utility asset. With only 7 million tokens up for grabs at an exclusive entry price of $0.35, this is a rare opportunity to secure early access to what many are calling the year’s most powerful utility asset. Early participants can join simultaneously on MultiBank.io, the Group’s regulated crypto exchange, and Uniswap, the world’s leading decentralized platform. Supported by $29 billion in real assets and powered by over $35 billion in daily turnover, $MBG is engineered
Live Story Raises €2.7 Million to Revolutionize the Digital Experience11.7.2025 10:05:00 CEST | Press release
With a round led by Vertis, the next-generation CMS platform accelerates its focus onAI, performance, and European expansion. Target: surpass €10M in recurring revenueby 2027. Live Story, the tech company founded by Stefano Mocellini, has closed a €2.7 million seed round led by Vertis, one of Italy’s leading early-growth venture capital firms. The funding will support the company’s international expansion and technological development, with a clear goal: to exceed €10 million in annual recurringrevenue by 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250711335560/en/ “We invested in Live Story because it addresses one of the major inefficiencies in digital commerce: the slow and rigid management of visual and narrative content,” says Alessandro Pontari, Partner at Vertis SGR. “The platform helps brands drastically reduce their time-to-market through a visual CMS that integrates seamlessly with any tech stack. In a wor
With a Score of 84 out of 100, Sagemcom Is Awarded the EcoVadis Platinum Medal: a Prestigious Recognition of its CSR Commitment11.7.2025 09:00:00 CEST | Press release
Sagemcom Group is proud to announce that it has been awarded, for the third time, the Platinum Medal by EcoVadis, the highest distinction granted by the leading global platform for assessing Corporate Social Responsibility (CSR) performance. This medal places Sagemcom in the top 1% of companies evaluated worldwide, across all industries. With a score of 84 out of 100, Sagemcom reaffirms its position as a committed leader in ecological transition, business ethics, sustainable supply chain management, and social responsibility. “The EcoVadis Platinum Medal is more than just an award — it is the recognition of our collective efforts to embed sustainable development principles at the heart of our corporate strategy and culture,” says Sylvaine Couleur, Executive Vice President, CSR & Communication. “Achieving this level demonstrates that our commitments are tangible, impactful, and internationally recognized. This distinction strengthens our determination to further advance and expand our C
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