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
Sofinnova Partners Closes Oversubscribed €82 Million Sofinnova MD Start IV Fund to Create the Next Generation of Medtech Companies28.9.2026 08:00:00 CEST | Press release
The new fund extends Sofinnova’s 20-year track record of company creation with capacity to launch six to eight new ventures across Europe and the US Sofinnova Partners ("Sofinnova"), a leading European life sciences venture capital firm based in Paris, London, and Milan, today announced the final close of Sofinnova MD Start IV at €82 million. The fund, which was oversubscribed, will help expand Sofinnova's medtech company-creation strategy across Europe and the US with greater capacity to launch new ventures and support them through key stages of development. With plans to launch six to eight new medtech companies over the next five years, Sofinnova MD Start IV will support ventures from inception through key clinical and operational milestones, providing founders with both capital and hands-on support. Sofinnova MD Start's approach combines clinical insight, entrepreneurial talent, and operational expertise to tackle significant unmet medical needs. The previous fund, Sofinnova MD Sta
Ant International’s Antom Upgrades Southeast Asia Leadership Structure to Drive Regional Synergy in the AI Era28.9.2026 07:18:00 CEST | Press release
Antom, a leading merchant payment and digitisation services provider under Ant International, today announced a series of key appointments for its operations in Southeast Asia to further strengthen the synergy among its regional brands and better serve regional merchants with streamlined full-stack AI-native solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260927431282/en/ Nabilah Alsagoff, co-founder and former chief operating officer of DOKU, Indonesia's leading payment fintech company, has been appointed as Head of Product, Antom SEA. In her new role, the payment veteran will oversee product development and innovation and drive a unified product roadmap for the overall SEA region. Chris Yeo, former chief executive officer (CEO) of DOKU, will take on the role as Head of Antom Philippines, and Country Head of 2C2P Philippines. With his long experience at DOKU, Grab and PayPal, Chris will also oversee the execution
UAE Opens 15th UN Congress on Crime Prevention and Criminal Justice and Launches Pledge4Justice with First Pledge of Up to USD 5 Million26.9.2026 22:51:00 CEST | Press release
The 15th United Nations Congress on Crime Prevention and Criminal Justice – Abu Dhabi 2026 kicked off today at ADNEC Centre Abu Dhabi. Set to run until 1 October, the Congress attracts representatives from over 97 countries, including over 32 ministers of justice and interior ministers, alongside senior officials, judges, prosecutors, experts, and youth from around the world. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260926005703/en/ UAE Opens 15th UN Congress on Crime Prevention and Criminal Justice and Launches Pledge4Justice with First Pledge of Up to USD 5 Million (Photo: AETOSWire) The opening session witnessed the adoption of the Abu Dhabi Declaration, which serves as the Congress's principal political and strategic outcome document and will guide international priorities and cooperation in crime prevention, criminal justice and the rule of law over the next five years. The Declaration is structured around four pi
Future Health Convenes Global Health Leaders at UNGA to Advance Health System Transformation at Scale26.9.2026 17:21:00 CEST | Press release
High-level dialogue explored how predictive and preventive health systems can deliver better health outcomes worldwide. Ministers, senior government representatives, and health leaders from 15 countries shared approaches to building health systems that predict risk, prevent disease, and support earlier intervention at population scale. Participants identified population-level data, financing, and delivery capacity as essential to turning earlier insight into action. Trust, community reach, and inclusive design were recognised as critical to ensuring that earlier insight and intervention are delivered effectively and equitably Future Health – A Global Initiative by Abu Dhabi convened Ministers, senior government representatives, and global health leaders in New York on the sidelines of the 81st Session of the United Nations General Assembly (UNGA 81). The high-level dialogue set out practical priorities for moving health systems from reactive treatment towards prediction, prevention, an
Mirum Pharmaceuticals and Incyte Announce U.S. FDA Approval of Atebrioz™ (zilurgisertib) for Adult and Pediatric Patients with Fibrodysplasia Ossificans Progressiva26.9.2026 01:00:00 CEST | Press release
-Once-daily oral ALK2 inhibitor approved to reduce the volume of total new heterotopic ossification in patients aged 12 years and older with FOP-Atebrioz expected to be available in the United States in October through Mirum Access Plus (MAP), with eligible patients paying as little as $0 per month-PROGRESS pediatric development program continues to evaluate zilurgisertib in children aged 2 to <12 years Mirum Pharmaceuticals, Inc. (Nasdaq:MIRM) and Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Atebrioz™ (zilurgisertib) tablets to reduce the volume of total new heterotopic ossification (HO) in adult and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva (FOP). The recommended dose of Atebrioz is 100 mg administered orally, once daily. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260925436454/en/ “Today marks an important milestone for pe
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