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
Onera Health and VitalAire Strategic Collaboration Closes the Gap Between Home Sleep Diagnostics and Sleep Apnea Therapy in Germany10.11.2026 14:55:00 CET | Press release
The Onera hPSG® solution meets the VitalAire homecare therapy network, giving physicians a faster path from diagnosis to treatment while patients retain full freedom to choose their homecare provider Onera Health, a leader in transforming sleep medicine, and VitalAire, the German homecare subsidiary of Air Liquide Healthcare, announced a collaboration to connect gold standard home-based sleep polysomnography diagnostics with sleep apnea therapy for patients across Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261110805161/en/ Ruben de Francisco (left), Founder and CEO of Onera Health, with Boyd Papprott (right), Director of Sales, Marketing & Product Management, Respiratory, at VitalAire Germany, at the DGSM 2026 conference in Wiesbaden. Access to in-lab polysomnography in Germany is limited, forcing patients to often wait a long time for a diagnosis. This collaboration lets physicians order a home PSG online for p
Sparxity Closes Series A, Bringing Total Funding to $90M10.11.2026 14:00:00 CET | Press release
Strategic funding accelerates next-generation sparse-native AI computing, building upon an existing commercial ecosystem and proven silicon Sparxity, a leader in sparse-native computing, today announced the close of its Series A, bringing cumulative funding secured by its team to $90M. The round was led by ICM HPQC Fund and joined by investors such as Lockheed Martin Ventures, GlobalFoundries, GS Futures, Cloudberry Ventures, TGFS and the EIC Fund. The financing also includes angel investments from TIME100 AI leaders Richard Socher (Recursive Superintelligence) and Nancy Xu (Salesforce-acquired Moonhub), alongside continued support from Atlantic and Silicon Catalyst. The funding will accelerate the development of specialized chips for fine-grained dynamic sparsity, targeting up to 44× faster AI inference in ultra-sparse models, bringing greater energy efficiency by computing only what matters. This press release features multimedia. View the full release here: https://www.businesswire.
Transition Industries Selects Technip Energies as PMC Partner for Pacifico Mexinol Ultra-Low Carbon Methanol Project10.11.2026 14:00:00 CET | Press release
Transition Industries announces the selection of Technip Energies as its Project Management Consultancy (PMC) partner for the Pacifico Mexinol project, located in Sinaloa, Mexico, which is expected to become the world's largest ultra-low carbon chemical production facility. Once operational, the facility will produce annually approximately 350,000 metric tons of RFNBO (Renewable Fuel of Non-Biological Origin) methanol and 1.8 million metric tons of ultra-low carbon methanol from natural gas with carbon capture, helping meet growing global demand through a lower-carbon production model. “We are pleased that Technip Energies has joined the project team and will bring their global project management expertise to our landmark industrial development project in Mexico. Technip Energies was selected for their project management expertise, technical know-how and execution capabilities,” says Diego Martinez, Transition Industries Chief Operating Officer. The project will use existing infrastruc
Telia Estonia trials Adtran 50G PON technology to prepare for next-generation broadband services10.11.2026 14:00:00 CET | Press release
News summary: Telia Estonia is preparing its fiber network to support the next generation of residential and business broadband services Trial of Adtran’s 50G PON solution establishes a practical path to higher-capacity access over existing infrastructure Project will validate how 50G PON can operate alongside GPON and XGS-PON services, enabling phased network upgrades Adtran today announced that Telia Estonia, part of Nordic and Baltic telecommunications operator Telia Company, is trialing its 50G PON technology as the next step in the evolution of its fiber broadband infrastructure. Building on its deployment of Adtran’s fiber access platform, the proof of concept (PoC) will evaluate how 50G PON can coexist with existing GPON and XGS-PON services on a common network infrastructure. The trial will help Telia Estonia prepare for future residential and business connectivity requirements while providing a practical framework for introducing higher-capacity services as market needs develo
Vasion® Fall Release Eliminates Dark Documents and Makes Operational Documents AI Ready10.11.2026 14:00:00 CET | Press release
New release puts AI agents, workflows and print into one control center for IT IT-Governed Document AI: Vasion Intelligence (beta) lets IT set guardrails up front while empowering users to easily create human in the loop workflows. Zero Trust Gap: A survey of 500+ U.S. IT leaders reveals print ranks last in Zero Trust coverage at just 16%. Live at Microsoft Ignite: Demos and benchmarking will run November 17–21 at Booth 5509. Vasion, the Intelligent Document Automation company, announced its fall release, which captures the context behind operational documents and makes them ready for AI without IT giving up control. Vasion will demonstrate it at Microsoft Ignite, November 17-21, in San Francisco, booth 5509. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261110362305/en/ Vasion® Fall Release Eliminates Dark Documents and Makes Operational Documents AI Ready “Every company runs on operational documents: the invoices, claims,
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