LFB Announces that the European Medicines Agency (EMA) Has Accepted for Filing the Marketing Authorization Application for eptacog beta (activated), a Recombinant Coagulation Factor VIIa
1.3.2021 16:00:00 EET | 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.
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/20210301005514/en/
Contact information
LFB:
Didier Véron - Executive VP Corporate Affairs
Tel: +33 (0)1.69.82.72.97 or +33 (0)6.08.56.76.54
verondidier@lfb.fr
HEMA Biologics Contacts (US):
Chris Macie, Senior Director, Medical Affairs
Cell number: (+1) 770-331-5761 - chris.macie@hemabio.com
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
Workiva Advances Regulatory Work with AI Innovation15.9.2026 18:00:00 EEST | Press release
Workiva Inc. (NYSE: WK), a leading, audit-ready platform for trust, transparency, and accountability, unveiled dozens of new product and platform innovations at Amplify 2026, the company’s annual conference attended by thousands of finance, accounting, sustainability, risk, and compliance leaders. Workiva Debuts Agent Studio Workiva introduced Agent Studio, a landmark platform capability that empowers users to quickly build, customize, and deploy AI agents in Workiva's trusted platform. By combining AI reasoning with Workiva's native platform capabilities, enterprise knowledge, and governed workflows, Agent Studio enables users to automate sophisticated manual business processes without writing any code. Organizations can enrich agents with company-specific knowledge and context, tailor them to their own processes, and schedule automations to execute recurring work. “With Agent Studio, we're putting the power to build in the hands of the people who know the work and their company the b
Study: Heatwaves Increase Cough Urge, Which Salt Aerosols Reduce15.9.2026 16:15:00 EEST | Press release
SC Therapeutics, with University North Carolina, Imperial College London, and Boston University, announced publication on Tuesday in Nature Scientific Reports of results from a multi-institutional study indicating that the aridity inherent in heatwaves increases cough hypersensitivity in human airways by collapsing mucus onto cilia in a manner common to chronic respiratory diseases, such as cystic fibrosis, and asthma. The researchers find that alkaline aerosols of magnesium salts reverse mucosal collapse for several hours, and reduce cough hypersensitivity as reflected in placebo-adjusted suppression of daily cough bout rate (59%, p=0.03) and persistence of suppression post treatment for 1 to 3 weeks in a randomized, double-blind, placebo-controlled study of 10 refractory chronic cough patients. “Paris recorded 5,764 excess deaths between 17 June and 2 July, a period of time during which we report atmospheric aridity in the city increased approximately 3-fold relative to the 35 year a
ADM’s Fourth Annual Regenerative Agriculture Report Highlights Growing Resilience Across the Food System15.9.2026 16:00:00 EEST | Press release
ADM (NYSE: ADM), a global leader in innovative solutions from nature, today released its fourth annual regenerative agriculture report, showing how its programs are supporting farmers, strengthening agricultural supply chains and delivering measurable environmental outcomes around the world. “Resilience starts on the farm. By improving and protecting soil health, farmers can be better equipped to adapt to changing conditions and maintain productive operations,” said Greg Morris, SVP and President, Ag Services and Oilseeds, ADM. “That resilience can extend across the value chain, helping strengthen the food system we all depend on.” In 2025, ADM’s regenerative agriculture programs engaged more than 56,000 farmers across approximately 4.6 million acres, 11 countries and 10 crops. Compared with regional benchmarks, the programs resulted in approximately 946,000 metric tons of CO₂e reductions. “ADM views agriculture as a powerful way to meet evolving customer needs, and our work in regener
Diligent Unveils New Agentic Capabilities in Diligent One to Power the Future of Governance, Risk and Compliance15.9.2026 16:00:00 EEST | Press release
Diligent, the AI leader in governance, risk and compliance (GRC) solutions, today announced a major enhancement to Diligent One, its native AI platform, at Gartner’s Enterprise Risk, Audit and Compliance Conference (ERAC). This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260915941016/en/ “For many organizations, GRC work is slowed by fragmented systems, manual coordination and time-consuming reporting processes,” said Brian Stafford, President and CEO of Diligent. “Our latest agentic capabilities help teams cut through that complexity by connecting context, surfacing what matters and driving faster execution — while keeping governance and professional judgement at the center." An orchestration agent that coordinates work and approvals The orchestration agent in Diligent One gives GRC professionals a natural-language interface to coordinate audit and risk work. Instead of simply answering questions, it enables users to describe
Unifocus Launches AI-Powered Platform to Transform Workforce and Operations Management in Hospitality15.9.2026 16:00:00 EEST | Press release
The global hospitality technology provider, Unifocus, has announced the launch of its newest AI platform, Unifocus Claira. Unifocus Claira is an industry first end-to-end workforce management and operations platform, purpose-built to give hoteliers and above-property hospitality organizations complete visibility across the workforce lifecycle through one cohesive system. By replacing the patchwork of disconnected tools, multiple technology stacks and siloed data systems that have traditionally been used to manage labor and operations processes, Unifocus Claira delivers one connected AI-native platform, providing customers with a comprehensive and organized view of their workforce and operations data. This unified data foundation powers advanced AI capabilities designed to accelerate decision-making, improve operational performance and drive business growth. Importantly, Unifocus Claira is also the first end-to-end platform of its calibre, purpose-built specifically for the select servi
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