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
1.3.2021 16:00:00 EET | 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.
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
Venture Global Commences Commercial Operations of Phase One of Plaquemines LNG1.11.2026 17:40:00 EET | Press release
On October 31, 2026, Venture Global (NYSE: VG) commenced commercial operations of the first phase of its second LNG export project – Plaquemines LNG – and the sale of low-cost, U.S. LNG to the first phase’s long-term customers. The commercial operations date (COD) for Phase 1 of Plaquemines LNG was reached in just over 53 months from the final investment decision on the project, making it among the fastest greenfield LNG projects ever completed. “Achieving commercial operations at the first phase of our second LNG project in 53 months is a testament to our team's relentless dedication and hard work,” said Venture Global CEO Mike Sabel. “We are thrilled to hit another major milestone that enables us to continue delivering reliable, affordable American LNG to the global market. We deeply appreciate the collaboration of our regulators and supply chain partners, whose shared commitment helped us deliver this project safely and on schedule.” The first post-COD cargo from Plaquemines Phase 1
From the Chishui to the Han: "Moutai Night" Debuts in Seoul to Bridge Cultural Connections1.11.2026 14:44:00 EET | Press release
On October 25, the 2026 “Moutai Night” was held in Seoul, South Korea, under the theme “Born by the Chishui River, Fragrance Along the Han River.” Over a hundred guests from China and South Korea gathered around the Han River, sharing the distinctive appeal of Chinese baijiu, and fostering cultural exchange between the two countries through fine liquor and culture. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261101047521/en/ The event featured an exhibition on Moutai’s brewing techniques and brand history. Hands-on experiences with Miao batik and silverwork showcased Guizhou culture, while creative cocktails brought Chinese spirits into dialogue with Korean tastes. A city-themed video, dance performances and a violin performance rounded out the program, as guests exchanged views on liquor culture in a warm atmosphere. As a flagship cultural initiative designed for global audiences, “Moutai Night” made its Seoul debut, fol
Vedanta Aluminium’s Q2FY27: Profit doubles to INR 6,187 Cr, EBITDA rises 83% YoY31.10.2026 15:12:00 EET | Press release
Vedanta Aluminium Metal Limited (BSE: 544780 & NSE: VAML), India’s largest aluminium producer, announced its unaudited financial results for the quarter and half year ended 30 September 2026, delivering solid financial and operational performance. Revenue increased to INR 22,066 crore, up 41% YoY, supported by higher volumes and improved marketing mix. EBITDA stood at INR 10,192 crore, up 83% YoY, with an EBITDA margin of ~46%. Profit after tax stood at INR 6,187 crore, more than doubling YoY with an increase of 105%. VAML strengthened its balance sheet during the quarter, reducing net debt by INR 3,090 crore QoQ, with Net Debt/EBITDA improving to 0.7x from 0.9x in Q1FY27. The company’s credit profile was validated with India Ratings upgrading its credit rating to AA+ (Stable), alongside rating reaffirmations from ICRA and CRISIL. Operationally, VAML achieved its highest-ever quarterly aluminium production of 649 KT, up 3% QoQ and 5% YoY. Value-added production reached a record 432 KT,
United States Signs Participation Contract for Expo 2030 Riyadh, Strengthening Momentum For Global Participation31.10.2026 10:38:00 EET | Press release
The United States of America has signed its Participation Contract for Expo 2030 Riyadh, marking a significant milestone in the World Expo’s preparations and further strengthening the momentum for international participation in the global event. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261031669001/en/ The Participation Contract was signed by His Highness Prince Faisal bin Farhan Al Saud, Minister of Foreign Affairs of the Kingdom of Saudi Arabia, and U.S. Secretary of State Marco Rubio, during a bilateral meeting held on the sidelines of the 2026 G20 Foreign Ministers’ Meeting in Atlanta, Georgia. The signing marks an important step in the United States’ journey towards Expo 2030 Riyadh, paving the way for the development of its pavilion, programming and visitor experience. It also reinforces the growing international commitment to Expo 2030 Riyadh, as countries move from confirming their participation to actively sha
ADNEC Group Kickstarts November with Two of the World’s Largest Events in the Energy and Tourism Sectors31.10.2026 05:53:00 EET | Press release
ADNEC Group, a Modon company, begins November by hosting two of the world’s most significant international events in the same week. ADIPEC 2026, the world’s largest energy event, takes place at ADNEC Centre Abu Dhabi from 2 to 5 November. Meanwhile, World Travel Market (WTM) London, one of the global travel industry’s leading gatherings, takes place at the Group’s Excel London venue from 3 to 5 November. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261030918463/en/ ADNEC Centre Abu Dhabi (Photo: AETOSWire) The two events, held simultaneously at the Group’s largest venues in the UAE and the UK, reflect ADNEC Group’s capability to deliver large-scale international events across multiple markets. ADIPEC has grown alongside the venue since it was first held at the ADNEC Centre Abu Dhabi in 2006. This year’s edition is set to be the largest in the event’s history, occupying the venue’s entire 153,000 square metres of exhibition
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