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
Rehlko Defines What It Takes to Build AI-Ready Power Infrastructure as Data Center Energy Demands Evolve4.8.2026 15:15:00 CEST | Press release
New eBook highlights how increasingly dynamic AI workloads are reshaping critical power requirements and explores strategies for building resilient, scalable energy infrastructure Rehlko, a global industrial energy resilience platform providing custom-engineered, integrated power solutions for mission-critical infrastructure worldwide, today released new insights on the power infrastructure requirements emerging from the rapid growth of large language models and artificial intelligence. In its latest eBook, AI Readiness Starts with Power: Designing for Real-World Load Conditions, Rehlko examines how increasingly dynamic AI workloads are reshaping expectations for data center power systems and highlights key infrastructure considerations for operators seeking to scale AI capacity reliably and efficiently. As the eBook outlines, AI readiness is increasingly defined not by installed capacity, but by how systems perform under highly variable real-world load conditions. The AI Power Challen
HappyRobot Raises $150 Million Series C to Build Enterprise Superintelligence4.8.2026 14:30:00 CEST | Press release
New funding led by Prysm Capital and co-led by Eurazeo will accelerate global growth as HappyRobot expands its engineering, deployment and go-to-market teams HappyRobot, the company putting AI agents to work across complex enterprise operations, today announced it has raised $150 million in Series C funding led by Prysm Capital and co-led by Eurazeo. Existing investors a16z, Base10, Y Combinator are doubling down with participation from strategics like Koch Disruptive Technologies (KDT), Orange, and T.Capital (Deutsche Telekom), Bankinter, Endeavor Catalyst, Kfund and Wave-X. The round values the company at $1.2 billion post-money, bringing total funding to around $200 million and marking a new stage of growth as enterprises deploy AI agents across mission-critical work. HappyRobot works with more than 150+ enterprise customers, including DHL, Kuehne + Nagel, Naturgy, Repsol, and Uber, and has grown 5x since raising its Series B late last year. After first proving its platform in logis
New 3D Flash Memory Technology from Kioxia and Sandisk Achieves Industry’s Highest Bit Density for QLC NAND4.8.2026 14:30:00 CEST | Press release
10th-generation QLC 3D flash memory represents a major leap forward for AI storage architectures, cloud platforms, and data‑intensive innovations Future of Memory and Storage Conference (FMS) – Kioxia Corporation, a subsidiary of Kioxia Holdings Corporation (TOKYO: 285A) and Sandisk Corporation (Nasdaq: SNDK) today unveiled their next-generation Quad-Level-Cell (QLC) 3D flash memory technology, which delivers up to 60% increase in bit density compared to their 8th-generation, surpassing 37 Gb/mm² and setting the industry benchmark1 for bit density, performance and power efficiency. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260804147821/en/ Leveraging the companies’ revolutionary CMOS directly Bonded to Array (CBA) technology2 which fabricates CMOS logic and the memory array on separate wafers before bonding them together with high-precision wafer-to-wafer alignment, the new generation improves read and write bandwidth c
Altasciences Completes Expansion of Research and Development Laboratory in Harleysville, Pennsylvania4.8.2026 14:00:00 CEST | Press release
Altasciences is excited to share it has expanded the R&D laboratory at its drug product formulation and manufacturing services facility in Harleysville, Pennsylvania, adding approximately 768 square feet of new laboratory space. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260804164599/en/ From left to right: Nasir Egal (General Manager, CDMO Services); Marie-Hélène Raigneau (Chief Executive Officer); Anuji Abraham (Senior Director, Pharmaceutical Development, CDMO Services); Robert Sabelli (Co-Chief Operating Officer); Cathy Konidas (Chief Administrative Officer) The expansion brings together formulation development and analytical testing within a single laboratory. This integrated setup is designed to accelerate decision-making, streamline workflows, and strengthen collaboration across scientific disciplines. “With this expansion, we are strengthening our focus on early-stage integration, bringing our CDMO capabilities t
Vasion® is Imprivata®-Ready Certified to Bring Trusted Identity Across Healthcare Print Infrastructure4.8.2026 14:00:00 CEST | Press release
New integration brings Imprivata Enterprise Access Management directly into the Vasion Platform: closing the identity gap at the print layer, enabling clinicians and healthcare users to securely release jobs at any printer with a single badge tap. Vasion, a leader in intelligent print automation, today announced a strategic integration with Imprivata, a leading digital identity and access management company for life- and mission-critical industries, starting with healthcare. The Vasion platform, with PrinterLogic®, PrinterLogic Output, and Vasion Automate, offers shared Imprivata customers a unified identity layer, spanning endpoints and printers, for secure, enterprise-wide visibility into every print job. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260804404337/en/ The integration is designed to maximize existing Imprivata deployments. No rip-and-replace is required. The Vasion platform works with the Imprivata infrastr
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