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
Organon Completes Divestiture of JADA® System to Laborie28.1.2026 18:45:00 CET | Press release
Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today the successful closing of the sale of its JADA® System to Laborie Medical Technologies Corp. Please see our prior announcement for a summary of the transaction terms. Indications for Use The JADA® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. Contraindications Ongoing intrauterine pregnancy Untreated uterine rupture Unresolved uterine inversion Current cervical cancer Known uterine anomaly Current purulent infection of vagina, cervix, or uterus For C-sections: Cervix <3 cm dilated before use of JADA Warnings Avoid excessive force when inserting JADA into the uterus or trauma to uterine wall may occur, including perforation. The safety and effectiveness of the JADA System in delivery at a gestational age <34 weeks or, if multiples, uter
Laserfiche Expands AI Data Capture with Auto-Classification to Transform Data into Business Intelligence28.1.2026 16:00:00 CET | Press release
New intelligent features automatically organize and classify documents, transforming how organizations manage information at scale. Laserfiche — the leading SaaS provider of intelligent content management — today announced major enhancements to its AI-powered data extraction tool, Smart Fields. The update introduces automated document classification and tagging, allowing organizations to move from unstructured content to informed decisions in seconds. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128228490/en/ Using natural language prompts instead of rigid, ruled-based OCR, Smart Fields can now identify document type — such as invoices, taxpayer identification forms, or student transcripts — and automatically apply the correct metadata template using AI. Users can also use Smart Fields to automatically add informational and security tags to files that meet certain criteria, defined using a natural language prompt. Users
Intersolar Africa 2026 to Position Nairobi as East Africa’s Key Hub for Solar and Energy Storage28.1.2026 15:20:00 CET | Press release
East Africa is emerging as one of the world’s most dynamic regions for solar power and battery storage. On 3–4 February 2026, Intersolar Africa will take place at the Sarit Expo Centre in Nairobi, expanding from the successful Intersolar Summit Africa in 2025 into a full international exhibition and conference. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128955267/en/ Intersolar Africa will take place on February 3-4 in Nairobi. East Africa’s Energy Market and Opportunities Rapid population growth, industrialization, and rising electricity demand are putting pressure on power systems across East Africa. Limited generation capacity, grid instability, and high electricity costs constrain economic growth. Solar photovoltaics combined with energy storage have emerged as the most cost-effective and scalable solution to expand capacity, stabilize supply, and strengthen long-term energy security for businesses and communities
Reply and the University of Milan Launch Experimental Research on Biological Computing Based on Cortical Labs’ CL1 Platform28.1.2026 15:10:00 CET | Press release
Reply [EXM, STAR: REY] today announced the start of a collaboration with the Department of Pathophysiology and Transplantation of the University of Milan, together with the “Centro Dino Ferrari” of the University of Milan - Ospedale Policlinico, for a new research and experimental initiative in the field of biological computing. The project aims to explore innovative approaches to learning and information processing through the integration of biological systems and digital technologies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128715625/en/ This initiative represents the starting point of an advanced research programme aimed at exploring new computational paradigms. At the core of the initiative is the CL1 biological computer developed by Cortical Labs, an Australian biotechnology company. Unlike conventional silicon-based computing architectures, this technology leverages the processing capabilities of living human
Brown Brothers Harriman Investor Services and SimCorp Forge Strategic Alliance to Provide Integrated End-to-End Technology, Data, and Services Solution for Global Asset Managers28.1.2026 15:00:00 CET | Press release
New offering leverages BBH Infomediary® to combine the benefits of the SimCorp One enterprise platform, including SimCorp Managed Business Services, with BBH Investor Services’ fund servicing and custody product suite. BBH Infomediary used to integrate BBH and SimCorp’s platforms and to connect to third parties in a unique open architecture model. Addresses the needs of global asset managers seeking to streamline and modernize their operating model. Quoniam Asset Management, a leading systematic manager, is the first to benefit from this data-driven offering. Brown Brothers Harriman (BBH), a privately held global financial services firm, and SimCorp, a leading global financial technology company, today announced a new strategic alliance to address the needs of global asset managers requiring an integrated, end-to-end technology, data, and services solution. Enhancing both firms’ existing offerings, this solution uses BBH Infomediary to integrate SimCorp One’s front and middle office ca
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