LFB
1.3.2021 14:02:06 CET | Business Wire | Press release
Regulatory News:
LFB today announced that the European Medicines Agency (EMA), the European regulatory authority, has accepted for filing the Marketing Authorization Application for eptacog beta, a recombinant coagulation Factor VIIa (rFVIIa).
The application includes data from three prospective phase 3 clinical trials (PERSEPT 1, PERSEPT 2, and PERSEPT 3) assessing the efficacy and safety of eptacog beta in the treatment of bleeding episodes in children and adults with congenital haemophilia A or B with inhibitors and for the prevention of bleeding in those patients undergoing surgery or invasive procedures. The final outcome from the EMA review is expected by mid-2022.
This announcement comes less than a year after the approval in April 2020 by the United States Food and Drug Administration (FDA) of LFB’s Biologics License Application (BLA) for the coagulation factor VIIa (recombinant)-jncw (eptacog beta), under the name SEVENFACT®, for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with haemophilia A or B with inhibitors. A sBLA efficacy supplement is currently under FDA review, with a regulatory outcome expected by mid-2021. An exclusive license for the commercialization of SEVENFACT® in the USA has been granted to HEMA Biologics, a joint venture between LFB and US WorldMeds.
In parallel, LFB announces the online publication of the exploratory in vitro study of eptacog beta in combination with emicizumab in the journal Haemophilia. 1 The combination of eptacog beta with emicizumab results in a concentration-dependent increase in thrombin generation in haemophilia plasma that remains below that of normal non-haemophilic plasma.
These exploratory study results provide in vitro data supporting the concept of eptacog beta use for the treatment of breakthrough bleeding in haemophilia patients treated with emicizumab. A clinical study is planned in the first quarter 2021 to further evaluate the use of SEVENFACT® in this patient population.2 The recommendation from the Medical and Scientific Advisory Council (MASAC) of the National Hemophilia Foundation in the USA supports the use of SEVENFACT® for the treatment of breakthrough bleeding in patients using emicizumab prophylaxis.3
About the exploratory in vitro study
The aim of this study was to determine the in vitro procoagulant activity of eptacog beta and emicizumab (alone and in combination) utilizing a thrombin generation assay with haemophilia A plasma with and without inhibitors.
A significant increase in peak thrombin, endogenous thrombin potential and velocity was observed for combinations of eptacog beta (0, 1, 2 or 5 µg/mL) with emicizumab (0, 50 or 100 µg/mL) in haemophilia A and haemophilia A plasma with inhibitors; the effect remained below that observed in normal, non-haemophilic plasma.
This study was sponsored by LFB. More details can be found in the study manuscript available at https://onlinelibrary.wiley.com/doi/full/10.1111/hae.14253
About LFB
LFB is a biopharmaceutical group that develops, manufactures, and markets plasma-derived medicinal products and recombinant proteins for the treatment of patients with serious and often rare diseases.
Created in France in 1994, LFB is today one of the leading European companies providing plasma-derived and recombinant medicinal products to healthcare professionals. Its mission is to offer patients new treatment options for unmet needs in three major therapeutic areas: immunology, haemostasis and intensive care.
LFB’s current market portfolio includes 15 biomedicinal products sold in over 30 countries.
Please visit www.lfb-group.com
for additional information.
About HEMA Biologics, LLC
HEMA Biologics is a biopharmaceutical company, located in Louisville, KY. HEMA Biologics has commercialization and distribution rights for SEVENFACT® in the USA and Canada. HEMA Biologics takes pride in the heritage of LFB, the developer and manufacturer of SEVENFACT®.
The company is dedicated to meeting the needs of patients living with rare bleeding disorders, supporting the community that cares for them, and bringing meaningful products and services to the marketplace to help improve their daily lives.
Please visit www.hemabio.com
for additional information.
1
Grandoni J, Duretz V, Bonzo D, et al. Exploratory in vitro evaluation of thrombin generation of eptacog beta (recombinant human FVIIa) and emicizumab in congenital haemophilia A plasma. Haemophilia 2021 Feb;
https://onlinelibrary.wiley.com/doi/full/10.1111/hae.14253
Online ahead of print.
2
ATHN16 study coordinated by the American Thrombosis and Hemostasis Network
: https://clinicaltrials.gov/ct2/show/NCT04647227
3
MASAC Document 263 - MASAC Recommendations Concerning Products Licensed for the Treatment of Hemophilia and Other Bleeding Disorders (Revised August 2020). National Hemophilia Foundation. Available at: https://www.hemophilia.org/sites/default/files/document/files/263_treatment.pdf
last accessed on February 7, 2020.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210301005514/en/
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
SecurityTech on the Rise: G+D Reports Strong Order Intake and High Resilience in 20252.4.2026 08:30:00 CEST | Press release
In fiscal year 2025, Giesecke+Devrient (G+D) reaffirmed its position as global leader in SecurityTech for mission-critical infrastructure. In a market where security is becoming essential for technological and societal stability, G+D demonstrates strong growth prospects. In 2025, G+D achieved a record order intake of €3.6 billion (+8%). Revenue increased to €3.2 billion (+1%), although exchange rate effects dampened growth. The key figures underscore the company's strong operational performance and profitability: Adjusted EBIT reached a new high of €211 million. The substantial free cash flow of €119 million provides additional leeway for future investments. With its equally strong segments – Digital Security, Financial Platforms and Currency Technology – G+D boasts a resilient portfolio that effectively cushions market volatility. The company's success reflects this strategic strength, combining technological depth, a global presence and operational reliability. G+D is making targeted
Bona Releases 2025 Sustainability Report2.4.2026 08:05:00 CEST | Press release
Bona®, a global, family-owned company that supplies products for installing, renovating, maintaining, and restoring premium floors, has published its 2025 Sustainability Report. The report outlines progress across Bona’s three sustainability pillars – Respect our Planet, Care for People, and Trusted Business – and highlights the continued integration of sustainability into all aspects of its operations. “Our business is built on extending the life of existing flooring materials and reducing the need for replacement,” says Lidija Broström, Interim Chief Executive Officer at Bona. “At Bona, we are making steady progress in reducing our impact while building a stronger foundation for the future. By working closely with our partners, we aim to drive meaningful change across our value chain and contribute to a more sustainable future.” In 2025, Bona reduced total Scope 1 and 2 greenhouse gas emissions (market-based) by 46% compared to its 2022 baseline, reaching 1,338 tonnes of CO₂—surpassi
The Estée Lauder Companies Fully Establishes Its “One ELC” Operating Model and Reaches Milestone in Its Profit Recovery and Growth Plan1.4.2026 23:00:00 CEST | Press release
WPP Appointed First-Ever Global Media Partner, Unifying Media Execution Worldwide“One ELC” Operating Model Is Transforming How the Company Operates at Scale The Estée Lauder Companies Inc. (NYSE: EL) today announced WPP as its first-ever global media partner, marking a significant advancement of its One ELC operating model, a scalable system designed to operate faster, execute with greater discipline, and drive growth. In fully establishing One ELC, the Company also reached a significant milestone in its Profit Recovery and Growth Plan’s (PRGP) Restructuring Program — a key action plan priority of Beauty Reimagined. Stéphane de La Faverie, President and Chief Executive Officer, The Estée Lauder Companies, said, “With the appointment of WPP as our first-ever global media partner, our One ELC operating model is now fully established. This more unified and scalable system will enable us to be faster, more agile and efficient, and support unlocking additional growth. Together with our exec
Visual Bank Expands “Qlean Dataset” to Support Large-Scale Japanese Speech Foundation Models1.4.2026 21:45:00 CEST | Press release
Delivering 100,000+ hours of rights-cleared Japanese audio, including regional dialects and culturally contextualized speech essential for commercial AI development. Visual Bank Inc. (CEO: Saneyuki Nagai), through its subsidiary amanaimages Inc., one of the largest digital asset providers for the marketing and advertising industry in Japan with over 40 years of history, today announced the expansion of its Qlean Dataset, a premium AI training data solution designed for developers building high-performance Japanese speech foundation models. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260401752248/en/ Visual Bank Group, leveraging over 40 years of expertise through amanaimages Inc., expands Qlean Dataset, delivering high quality, rights cleared Japanese language corpora, including 100,000+ hours of commercially usable audio. A new development within the Qlean Dataset division, which focuses on providing datasets for institu
Manna Air Delivery Raises $50Million Series B as It Announces Plans to Expand in the United States1.4.2026 18:00:00 CEST | Press release
ARK Invest, backer of OpenAI, Anthropic, Tesla and SpaceX, the Ireland Strategic Investment Fund and Schooner Capital back new round bringing total funding to $110M Plans to scale to 40 bases in the United States, supported by seven years of operational orchestration experience, and recently expanded its global partnerships with Uber, joining Deliveroo, Just Eat and DoorDash in delivering everyday items by air. Manna Air Delivery, a global leader in consumer drone delivery, has announced a $50 million funding round to scale its proven operations further in the United States and Europe. The round brings Manna’s total funding to $110million. Manna now operates one of the most active consumer drone delivery networks in the world, with more than 250,000 regulated commercial UAV flights completed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260310714366/en/ Manna Air Delivery raises $50m Series B Investors in the round include
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