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
Dryad Networks Reaches XPRIZE Wildfire Finals Milestone, Demonstrating Autonomous Detection and Suppression of Wildfires in Alaska8.7.2026 17:00:00 CEST | Press release
Dryad Networks, the leader in ultra-early wildfire detection technology, today announced a major achievement in the finals of the Autonomous Wildfire Response track of XPRIZE Wildfire, a four-year, $11 million global competition accelerating new solutions to end destructive wildfires. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707802818/en/ The Silvaguard Suppression Drone can deliver a 100 liter liquid suppressant to autonomously suppress small wildfires detected by Silvanet Competing against just two other finalists selected from an original field of nearly 300 teams worldwide, Dryad successfully demonstrated the integrated capabilities of its Silvanet wildfire detection network and Silvaguard autonomous firefighting drone system during final testing in remote Alaska. The XPRIZE Wildfire finals challenged teams to autonomously detect and suppress a wildfire without any human intervention across a vast 1,000 square k
Rigaku Opens "Rigaku Solutions Center Osaka" to Strengthen Global Semiconductor Metrology Service Capabilities8.7.2026 17:00:00 CEST | Press release
- Centralizing and Expanding Practical Training to Strengthen Global Service Capabilities - Rigaku Corporation, a global solution partner in X-ray analytical systems and a group company of Rigaku Holdings Corporation (headquarters: Akishima, Tokyo; CEO: Jun Kawakami; “Rigaku”), has opened the Rigaku Solutions Center Osaka (RSC-Osaka) at its Osaka Plant. The new facility centralizes and expands practical training for field service engineers supporting semiconductor metrology systems, strengthening Rigaku's global service capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708402770/en/ Photo: Hands-on training using the TXRF-V310 at RSC-Osaka As semiconductor manufacturing processes continue to advance toward finer geometries, higher layer counts, and more complex three-dimensional structures, semiconductor metrology systems require ever greater precision and operational stability. X-ray analytical technologies pl
Cardiac Dimensions® Announces Three Major Publications Demonstrating Long-Term Durability, Real-World Performance, and Broad Patient Benefit of the Carillon Mitral Contour System®8.7.2026 16:05:00 CEST | Press release
New data highlight multi-center 5-year durability, 10-year survival, and the largest single-center experience across both HFrEF and HFpEF patients with functional mitral regurgitation Cardiac Dimensions, a leader in transcatheter therapies for heart failure, today announced the publication of three major manuscripts that together form the most comprehensive evidence base ever assembled for transcatheter indirect mitral annuloplasty. These publications span a five-year multi-center commercial registry, the largest single-center experience across both preserved and reduced ejection fraction, and long-term survival results through ten years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707656796/en/ Carillon Mitral Contour System® The Carillon Mitral Contour System is the only commercially available indirect mitral annuloplasty device, designed to treat a broad and expanding population of patients living with functional mi
First Randomized Controlled Trial Shows Promise of a Ketogenic Diet in Psychotic Disorders8.7.2026 15:00:00 CEST | Press release
Trial reports correlations between ketone levels and cognitive and psychiatric symptoms in individuals with schizophrenia-spectrum and bipolar-1 disorders Published today in Schizophrenia Bulletin, a first-of-its-kind randomized controlled trial (RCT) from researchers at the University of California, San Francisco (UCSF), and funded in part by the National Institute of Mental Health (NIMH), adds to growing literature on the potential benefit of a ketogenic diet for treating psychotic disorders. The study, which enrolled participants with schizophrenia-spectrum or bipolar-1 disorders, demonstrated rapid metabolic improvements with a ketogenic diet compared to diet-as-usual during an initial one-month RCT open-label phase. Furthermore, those who continued with the optional four-month single-arm ketogenic diet extension saw meaningful gains across metabolic, psychiatric, and cognitive measures. This press release features multimedia. View the full release here: https://www.businesswire.co
Teamily AI Publicly Launches Human+AI Social Platform to Make Building and Growing a Company Easy for Every Team8.7.2026 15:00:00 CEST | Press release
Teamily AI (https://Teamily.ai), together with its Agentic AI Infra platform TensorOpera AI (https://TensorOpera.ai), today announced the public launch of its Human+AI social platform, a product stack that has already served more than 5 million users around the world. Starting today in Palo Alto and rolling out simultaneously across dozens of countries, this first public launch opens the full stack to everyone with a single mission: to make building and growing a company easy for every person and every team. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708584390/en/ "This is the moment we open our doors to the world," said co-founders Dr. Aiden Chaoyang He and Professor Salman Avestimehr. "We want every person and every team to be able to move from idea to product, from product to market, and from market to growth and investment, with an AI-native team by their side." At its core, Teamily AI enables humans and AI agents
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