Business Wire

Octapharma announces FDA approval of updated NUWIQ® Prescribing Information to include immunogenicity data in previously untreated patients

Share

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.

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

Dixa, the Next-Gen CX Platform, Raises $105M Series C to Transform Customer Service Worldwide28.7.2021 15:30:00 EEST | Press release

Founded as a customer service solution that evolved into a customer engagement platform, European company Dixa today announced a Series C funding round totaling $105M. The company is leading the change from customer service to value creation with a multiexperience approach, challenging the status quo and delivering value-driven experiences that generate results for businesses. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210728005430/en/ Dixa Founding Team (Photo: Business Wire) The Series C round is led by General Atlantic, a leading global growth equity investor with a history of backing and scaling companies that transformed their industries, with participation from existing investors Notion Capital Project A and Seed Capital. Dixa will leverage the new funds to invest in product development, including potential new acquisitions (following Dixa’s acquisition of Melbourne-based Elevio in January 2021), and plans to quadr

V.E, Part of Moody’s ESG Solutions, Provides Second Party Opinion on the Kingdom of Spain’s Sovereign Green Bond Framework28.7.2021 15:30:00 EEST | Press release

Moody’s ESG Solutions Group announced today that V.E has provided a Second Party Opinion (SPO) on the Kingdom of Spain’s Sovereign Green Bond Framework. The Framework is aligned with the four core components of the Green Bond Principles 2021 and follows best market practices identified by V.E. Net proceeds of the bonds will exclusively be used to finance or refinance projects tied to the country’s environmental objectives, including renewable energy, biodiversity protection, and climate change adaptation. “The bonds issued under Spain’s Framework will provide an ‘advanced’ contribution to sustainability, the highest score on our four-point scale,” said Patrick Mispagel, MD – Sustainable Finance at Moody’s ESG Solutions. “Our assessment reflects that in many cases Spain’s Framework followed the detailed technical eligibility criteria of the EU Taxonomy Climate Delegated Act. We expect to see additional sovereign issuances as nations increasingly seek to raise capital to support climate

U.S. Food and Drug Administration Grants Breakthrough Therapy Designation to Takeda’s Investigational Compound, TAK-994, an Oral Orexin Agonist in Clinical Development for Narcolepsy Type 1 (NT1)28.7.2021 15:15:00 EEST | Press release

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to TAK-994,1 its Phase 2 investigational oral orexin agonist, which is designed to selectively target orexin 2 receptors. TAK-994 is currently being studied for the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy type 1 (NT1),2 a chronic neurological disorder that alters the sleep-wake cycle.3 EDS is a hallmark symptom of NT1 and is characterized by a person’s inability to stay awake and alert throughout the day, and falling asleep unintentionally or at inappropriate times on a daily basis.3,4 The FDA’s Breakthrough Therapy Designation process is designed to expedite the development and review of a drug that is intended to treat a serious condition, for which preliminary clinical evidence exists indicating it may demonstrate a substantial improvement over available therapies on at

BlueConic is the First Customer Data Platform to Offer a Data Clean Room Solution28.7.2021 15:02:00 EEST | Press release

Driven by the death of the third-party cookie and its debilitating impact on the digital advertising industry, data clean rooms are growing in popularity among brands and publishers alike. To meet this demand, BlueConic is proud to announce its own comprehensive data clean room solution, making it the first customer data platform (CDP) to do so. The move will enable its customer base of over 300 companies worldwide to facilitate second-party data sharing in a privacy-safe environment. The solution provides brands and publishers with a privacy-compliant way to combat the effects of Apple and Google’s decisions to deprecate the use of third-party cookies in their respective web browsers, Safari and Chrome. Without such a solution, marketers will lose the ability to measure the impact of digital advertising spend once and for all. Industry analysts agree that BlueConic is uniquely poised to offer such a solution. Unlike other data clean rooms on the market, BlueConic’s solution will: Insu

Vertex to Initiate Phase 3 Development Program for New Once-Daily Triple Combination Regimen in People With Cystic Fibrosis28.7.2021 15:00:00 EEST | Press release

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the company will initiate a Phase 3 development program for the new once-daily investigational triple combination of VX-121/tezacaftor/VX-561 (deutivacaftor) in the second half of 2021. The combination of VX-121/tezacaftor/VX-561 was first identified as having potential for increased efficacy based on its ability to drive higher levels of chloride transport compared to TRIKAFTA® (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in human bronchial epithelial cells in vitro. The combination of VX-121/tezacaftor/VX-561 was evaluated in a Phase 2 study in people with cystic fibrosis (CF) ages 18 and older with one F508del mutation and one minimal function mutation (F/MF) and in people with CF ages 18 and older with two F508del mutations (F/F). The regimen was generally well-tolerated, and the study met the primary efficacy endpoint of absolute change from baseline in ppFEV1 and all secondary efficacy endpoints including abso

Discover the History of Pisco, the Spirit Drink That Was Born in Peru 400 Years Ago28.7.2021 14:00:00 EEST | Press release

Every lover of spirits should know about pisco. Therefore, it is not surprising that this distillate has achieved international notoriety and been included as a de rigueur item of the ultimate bucket list in “Captain America: Winter Soldier” in 2014. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210728005437/en/ (Photo: Business Wire) What many don't know is its origin and the fascinating journey it would make 200 years later: in 1553, the vines of the Canary Islands arrived in Peru with the strains that gave rise to pisco (Quechua word for “bird,” which is also the name of a Peruvian city founded in 1640 by viceroy Pedro Toledo y Leyva) and in 1779, navigator Francisco de la Bodega y Quadra took this drink from Pisco (Peru) to San Francisco for the first time, when both cities were still part of the Spanish empire. Thus, in 1850 the Pisco Punch was created, the flagship cocktail for the entire West Coast of the United Stat

FRISS Raises $65 Million Series B Funding Led by Accel-KKR28.7.2021 14:00:00 EEST | Press release

FRISS, the most widely adopted provider of AI-powered end-to-end fraud prevention and detection solutions for P&C insurers worldwide, today announced it closed a $65 million Series B funding round led by Accel-KKR, advised by FT Partners and endorsed by existing investor, Aquiline. The funding will fuel the company’s rapid growth with additional product innovations, deep market penetration and lines of business expansions. FRISS serves insurers in over forty countries today, and is well on track to deliver over $2 billion in fraud savings to insurers in 2021 alone. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210728005113/en/ FRISS Raises $65 Million Series B Funding Led By Accel-KKR (Graphic: Business Wire) Insurance fraud is a large and growing problem faced by insurance companies, with estimates of fraud in as much as 10-17% of total claims paid annually – a staggering $80 billion annual loss in the US insurance market

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