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
DDN Selected to Modernize Research Data Infrastructure at UNSW Sydney26.10.2026 23:30:00 EET | Press release
DDN, the global leader in AI and data intelligence solutions, today announced that UNSW Sydney has selected DDN to deliver a new research data storage environment as part of the university’s Research Data Experience (RDE) program. Working with Australian software company Arcitecta, DDN will combine its EXAScaler parallel file system with Arcitecta’s Mediaflux® data management platform to help researchers spend less time managing data and more time using it. Following an extensive 18-month evaluation, UNSW selected an integrated approach that will replace 11 legacy storage systems with a coordinated environment for high-performance storage and enterprise data management. The decision reflects a broader challenge facing research-intensive institutions: how to support rapidly expanding scientific datasets while simplifying infrastructure, improving data accessibility and managing long-term costs. Built for data-intensive research, high-performance computing and AI workloads, DDN EXAScaler
Agent Assurance by TestMu AI Is Now Generally Available, Letting Teams Test What Their AI Agents Actually Change26.10.2026 17:15:00 EET | Press release
TestMu AI (formerly LambdaTest), the world's first Agentic AI-powered Quality Engineering platform, today announced the general availability of Agent Assurance. Agent Assurance tests AI agents that take actions, such as calling tools, writing files, and changing records, by checking what a run actually changed rather than what the agent says it did. Any team can now create a TestMu AI account and run it against its own agent without booking a demo first. Agent Assurance launched on August 17, 2026, behind a waitlist and a guided onboarding session. Since then, Rook, the CLI that runs Agent Assurance, has shipped a steady run of releases, shaped by feedback from early teams. Agent evaluation has mostly graded the final reply, and that reply can be wrong about the agent's own work. In CXBench, a benchmark of LLM agents in regulated customer-experience workflows published in October 2026, 80.1% of runs that reached the right outcome still failed the process checks, and only 13.8% passed b
Actiphy Announces ImageServer for Centralized Backup Storage and Post-Backup Processing26.10.2026 17:13:00 EET | Press release
Actiphy™, Inc., a provider of backup, disaster recovery, and virtualization software, today announced Actiphy ImageServer™, a centralized platform for storing, managing, verifying, and replicating backups created with ActiveImage Protector™. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026410729/en/ Actiphy ImageServer Console ImageServer combines the management capabilities of Actiphy ImageCenter™ with the secure storage of Actiphy StorageServer™. By moving Verify, Replication, Consolidation, and BootCheck™ to a dedicated server, ImageServer reduces processing load on protected systems and simplifies backup administration. As organizations protect more systems and retain more backup generations, storage and administrative demands grow. ImageServer addresses these challenges by centralizing backup storage and management and automating post-backup processing. Key capabilities include: Inter-File Deduplication™ — Identifi
Dubai Chambers Launches World's First Agentic AI Marketplace by a Chamber of Commerce26.10.2026 17:06:00 EET | Press release
Dubai Chambers has launched Chamber AI Hub, the world's first Agentic AI marketplace developed by a chamber of commerce, enabling businesses in Dubai to access ready-to-use AI agents that independently perform a range of administrative and operational tasks. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026467531/en/ H.E. Sultan bin Saeed Al Mansoori Chairman of Dubai Chambers. (Photo: AETOSWire) The marketplace currently offers 22 specialised AI agents across seven business functions including Compliance, Procurement, Operations, Finance, Sales, Human Resources, and Logistics. The offering is set to expand to 100 agents. The initiative supports Dubai's efforts to accelerate the adoption of Agentic AI across the private sector, helping businesses enhance efficiency, strengthen competitiveness, and transform their operating models. H.E. Eng. Sultan bin Saeed Al Mansoori, Chairman of Dubai Chambers, commented: “Success in
Media Release: Allianz Beach Arena for the LA28 Olympic and Paralympic Games Joins the Allianz Family of Stadiums26.10.2026 16:37:00 EET | Press release
For the first time in Olympic and Paralympic history, a competition venue will carry the Allianz name. The Allianz Beach Arena in Long Beach, California, for the LA28 Olympic and Paralympic Games will become the newest member of the Allianz Family of Stadiums. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261026919959/en/ Allianz's "custom A" emblem for LA28. From Horse Guards Parade in London to Copacabana Beach in Rio and the Eiffel Tower in Paris, Olympic Beach Volleyball has always found its home in iconic settings around the world. At the LA28 Games, that home will carry the Allianz name. Allianz is proud to help celebrate this exciting sport in Long Beach, a city in the southern part of Los Angeles County where beach volleyball is part of everyday life and local culture. Set right on the Long Beach waterfront, the nearly 15,000 seat temporary arena will host the Olympic Beach Volleyball and the Paralympic Blind Footba
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