LFB Announces that the European Medicines Agency (EMA) Has Accepted for Filing the Marketing Authorization Application for eptacog beta (activated), a Recombinant Coagulation Factor VIIa
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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20210301005514/en/
Contact information
LFB:
Didier Véron - Executive VP Corporate Affairs
Tel: +33 (0)1.69.82.72.97 or +33 (0)6.08.56.76.54
verondidier@lfb.fr
HEMA Biologics Contacts (US):
Chris Macie, Senior Director, Medical Affairs
Cell number: (+1) 770-331-5761 - chris.macie@hemabio.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
IonQ and Swiss Consortium Launch First Citywide Dedicated Quantum Network in Geneva5.11.2025 23:04:00 EET | Press release
IonQ (NYSE: IONQ), the world’s leading quantum company, with luminary Swiss partners, successfully deployed a citywide quantum network in Geneva, Switzerland. This consortium of world-class academic, enterprise, and public institutions will advance quantum cybersecurity and communications research, collaboration, and innovation. The new infrastructure, named the Geneva Quantum Network (GQN), is the nation’s first dedicated quantum network connecting key institutions across the region. “Our involvement in the GQN alongside globally-renowned companies such as Rolex and research leaders like CERN, underscores our IP and pioneering leadership in quantum cybersecurity and communication,” said Niccolo de Masi, Chairman and CEO of IonQ. “IonQ is leveraging existing fiber optic infrastructure to link partners across the Geneva region. Our partnership with leading universities, government, and industry players in Geneva is enabling real-world quantum communications, accelerating research, and b
PPG sets paint stirring world record at SEMA 2025 to highlight benefits of new automated system for body shops5.11.2025 20:41:00 EET | Press release
PPG (NYSE: PPG) today announced that it achieved a GUINNESS WORLD RECORDS™ title for the largest simultaneous paint stirring challenge during a customer event at the 2025 SEMA Show in Las Vegas. More than 275 participants stirred paint together to highlight the manual effort still common in collision repair before PPG unveiled its new SEM MIX’N’SHAKE™ automated stirring solution. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105923792/en/ More than 275 participants simultaneously stirred paint at SEMA 2025 as PPG breaks the GUINNESS WORLD RECORDS™ title for the largest paint stirring challenge as it unveiled the SEM Mix’n’Shake™ automated stirring system. The SEM Mix’n’Shake system produces a fully homogenized car paint mix in less than 60 seconds. By automating this step, body shops can reduce rework and recover up to 6% more productive work hours annually. The system also improves paint consistency, efficiency and work
Quectel Unveils New Smart Single Board Computers (SBC) to Help Accelerate Intelligent Device Development, Rapid Prototyping and Cutting Development Costs5.11.2025 19:00:00 EET | Press release
Quectel Wireless Solutions, an end-to-end global IoT solutions provider, has launched three new smart single board computers (SBC). The QSM368Z, QSM560DR, and QSM668SR are designed to give developers more choice and speed up product development of intelligent solutions and digital transformation. Each board is cost-effective, fully certified, and offers a wide range of options for connectivity, operating system and memory options to suit different application needs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105179097/en/ Quectel unveils new smart single board computers (SBC) to help accelerate intelligent device development, rapid prototyping and cutting development costs “These boards are fully finished hardware that can be easily integrated inside customers’ larger systems across a wide range of IoT use cases,” commented Raymond Wang, Head of Smart SoC, Quectel Wireless Solutions. “Provided in a ready-to-use, singl
First in Human Ischemic VT Ablation Successfully Performed in iCMR5.11.2025 17:55:00 EET | Press release
Imricor Medical Systems, Inc. (Company or Imricor) (ASX: IMR), together with Amsterdam University Medical Centre (Amsterdam UMC), is pleased to announce the successful completion of the first Ischemic Ventricular Tachycardia (VT) ablation ever performed under real-time MRI guidance in an iCMR lab. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105120761/en/ Imricor’s NorthStar® Mapping System The Amsterdam UMC team, shown here, performed the VT ablation procedure following previous experiences performing atrial flutter and premature ventricular complex (PVC) ablation procedures guided by real-time MRI and Imricor’s NorthStar® Mapping System. Regarding the VT procedure, Dr. Kemme, stated: “This procedure is part of an international research programme. The MRI imaging shows us precisely where the myocardial infarction took place; therefore, we can send the catheter to the exact spot. This information can make ablation possi
SIS Medical AG Welcomes the Results of the VICTORY Trial Demonstrating Non-inferiority of OPN NC to Intravascular Lithotrispy (IVL) for Lesion Preparation and Stent Expansion in Severely Calcified Lesions5.11.2025 17:12:00 EET | Press release
SIS Medical AG, a Swiss manufacturer of the Super-High-Pressure PTCA balloon catheter (OPN NC), is pleased to announce that the results of the investigator-initiated VICTORY trial were presented during the late-breaking clinical session at TCT 2025 by the Cardiovascular Research Foundation (CRF). The randomized, multi-center clinical study was designed to compare the safety and efficacy between the OPN and IVL devices for lesion preparation and optimized stent expansion in highly complex calcified coronary lesions, deploying a drug-eluting stent (DES). Coronary artery calcium affects approximately one-third of patients undergoing PCI and is a key contributor to procedural and stent failure. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251105812157/en/ "With a similar safety profile, OPN can be a feasible and faster alternative to IVL." Dr. M. Bossard, Senior Physician at Luzerner Kantonsspital, Switzerland A total of 282 p
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