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
Thales Secures Significant U.S. Army LOCODA Radio Order Following Rapid Development Push23.6.2026 19:42:00 CEST | Press release
The U.S. Army has selected the Thales Radio Adaptable Transport (RAT) to support the Service’s Low Cost Data Architecture (LOCODA) tactical communications transformation effort. Rapidly developed and production ready, LOCODA RAT delivers scalable, modular, multi-transport voice and data connectivity designed to support evolving operational requirements across current and future mounted platforms. Built on a commercial-off-the-shelf and non-developmental item approach, LOCODA RAT scales production, supports continuous upgrades, and reduces integration complexity and lifecycle costs. Delivering capability at mission speed, Thales subsidiary, Thales Defense & Security, Inc. (TDSI), has secured an order for up to 5,000 Low Cost Data Architecture (LOCODA) Radio Adaptable Transport (RAT) platforms. The Thales RAT solution, which was conceived, developed and field-ready less than four months, modernizes voice and data communications and integrates effortlessly into radio mounts across all cur
Epicor Prism Launches Across European Markets, Bringing Embedded, Industry-Specific AI to Manufacturers23.6.2026 17:55:00 CEST | Press release
New AI capabilities help organisations enhance operational decision-making Epicor has expanded its AI-driven ERP strategy in the UK and select European markets with the general availability of Epicor Prism, a portfolio of vertical AI agents designed specifically for the supply chain industries. Embedded directly in Epicor Kinetic, Epicor Prism gives customers conversational access to live ERP data and related documents without needing specialised analytics skills or separate AI tools. The launch reflects a broader shift in ERP from systems of record to systems of outcomes that help users interpret data, make decisions and take action in real time — a transformation Epicor calls Cognitive ERP. Responding to pressure on productivity and skills European manufacturers are under growing pressure to raise productivity, strengthen supply chain resilience and remain globally competitive despite workforce constraints and ongoing digital skills shortages. While many organisations continue to inv
Airship Appoints Laura Zwahlen as Chief Revenue Officer23.6.2026 17:00:00 CEST | Press release
Go-To-Market and Revenue Operations Veteran to Lead Global Sales and Customer Success Organizations into the Next Phase of Growth Airship, the mobile-first customer experience company, today announced the appointment of Laura Zwahlen as Chief Revenue Officer (CRO). Zwahlen will oversee all global revenue-generating activities, driving the alignment, execution, and strategy across Airship’s sales, account management, and customer success teams to accelerate the company’s market leadership and customer impact. She will report directly to CEO Brett Caine. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623145620/en/ Laura Zwahlen, Chief Revenue Officer (CRO) of Airship Zwahlen brings more than 20 years of go-to-market and revenue leadership experience, with a proven track record of guiding technology organizations through rapid growth, strategic acquisitions, and public offerings. Previously, she served as CRO at NextRoll (th
INRIX Data Reveals How the 2026 FIFA World Cup Is Reshaping Traffic Across 11 U.S. Cities23.6.2026 16:56:00 CEST | Press release
With unsurpassed data scale and speed, INRIX is the definitive ongoing source for World Cup transportation analysis INRIX, a global leader in transportation data and analytics, today announced the launch of its 2026 FIFA World Cup Data Hub, providing transportation agencies, event organizers, media, and travelers with a comprehensive, real-time view of how the world’s largest sporting event is moving millions of people. The 2026 FIFA World Cup spans 16 cities across the United States, Canada, and Mexico, making it the most geographically diverse World Cup in history. With matches across 11 U.S. stadiums attracting millions of fans from around the world, transportation demands vary as widely as the cities themselves. INRIX is uniquely positioned to capture that complexity at scale with unprecedented speed, backed by a data infrastructure no other company can beat. Drawing on more than 300 million connected vehicles and devices, a 50-petabyte transportation data lake, and 44 billion data
IQM achieves milestone in quantum error correction, enabling fault-tolerant computing in the near-term23.6.2026 16:41:00 CEST | Press release
New research introduces a family of error-correcting codes that reduce qubit overhead by up to 1,000 times compared to today’s leading approach — without requiring any new hardware. IQM Quantum Computers, the global leader in superconducting quantum computers, today announced a significant achievement in quantum error correction, using directional tile codes, marking a major step toward practical, large-scale fault-tolerant quantum computing. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260623243333/en/ IQM achieves milestone in quantum error correction, enabling fault-tolerant computing in the near-term The research, available on arXiv, and co-authored by IQM researchers and collaborators at Freie Universität Berlin, the University of Edinburgh, and Johannes Gutenberg-Universität Mainz, introduces ‘directional tile codes’, a new family of quantum error-correcting codes that resolves one of the central tensions in quantum
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