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
K2 Partnering Solutions Appoints Srinivas Rao as Chief Executive Officer16.2.2026 11:00:00 EET | Press release
K2 Partnering Solutions, a global leader in consultative technology and talent solutions, today announced the appointment of Srinivas Rao as Chief Executive Officer. Srinivas is a seasoned global executive with more than 28 years of experience driving value creation, scalable growth, and operational transformation across digital, consulting, IT services, and business services. He brings deep expertise in leading complex, multi-market organisations and has successfully scaled $800M+ P&Ls, working closely with boards, sponsors, and executive leadership teams across the USA, UK, Europe, the Middle East, and APAC. Most recently, Srinivas served as Chief Business Officer and a member of the Executive Council at LTIMindtree, where he was accountable for growth acceleration, market expansion, strategic customer relationships, and operating performance across a highly complex regional footprint. During his tenure, he played a pivotal role in strengthening go-to-market execution, driving margin
Klarna Launches on Google Pay in the UK16.2.2026 10:00:00 EET | Press release
Klarna, the global digital bank and flexible payments provider, is now available on Google Pay in the UK. Google Pay users in the U.K. can choose Klarna’s interest-free payment options at checkout. Raji Behal, Head of Western and Southern Europe, UK & Ireland at Klarna, said, “We’re really excited to bring Klarna’s fair, flexible and interest-free payment options to Google Pay users. This is a big moment for us and a major step towards our goal of being available at every checkout, everywhere. Together with Google, we’re making it easier than ever for millions of shoppers to choose Klarna and pay in a smarter, more transparent way — all from their phone.” Lisa Yokoyama, Director of Product Management at Google Paysaid: "Expanding our collaboration with Klarna to the U.K. underscores our goal to empower more people with the flexibility to pay how they choose. With people shopping on Google over a billion times a day, this broader footprint provides even more checkout options to help bus
Italy Sees Economic Boost From the Opening Weekend of the Olympic Winter Games Milano Cortina 202616.2.2026 10:00:00 EET | Press release
Visa, the Official Payment Technology Partner of the Olympic and Paralympic Winter Games, today released new data revealing consumer spending patterns in the Winter Games host locations1 during the opening weekend of the Olympic Winter Games Milano Cortina 2026. VisaNet data analysed by Visa Consulting & Analytics (VCA) shows the positive impact that Milano Cortina 2026 is having on commerce: Overseas Visa cardholders visits rose by more than 60%, with the largest share of visitors coming from the U.S. (+160% year-on-year), followed by China, Brazil, Canada and Japan. In Europe, Visa cardholders from Germany represent the largest share of visitors (31% year-on-year increase), followed by Switzerland, France and the UK. International Visa cardholders spent more than in the previous year, with the U.S. leading the year-on-year growth with a 125% increase in their spending, followed by Canada and Switzerland. Visitors from Germany, China and the U.S. ranked as the top spenders, with an av
New ECCO data show subcutaneous (SC) infliximab (Remsima ™ SC) effectively recaptures and maintains disease control after drug holiday16.2.2026 09:00:00 EET | Press release
Celltrion, Inc. today announced new data from a post-hoc analysis of the pivotal LIBERTY studies (LIBERTY-CD and LIBERTY-UC), showing that subcutaneous (SC) infliximab restored and maintained response in most Crohn’s disease (CD) and ulcerative colitis (UC) patients with sustained efficacy, safety, and persistence through to Week 102.1 The data will be presented as a poster presentation at the 21st Congress of the European Crohn’s and Colitis Organisation (ECCO), to be held from February 18-21 in Stockholm, Sweden. “As immunogenicity is the most significant concern when restarting treatment with infliximab after an interruption, these results suggest that treatment persistence was maintained even in patients with immunogenicity,” said Dr. Marla Dubinsky, Professor of Pediatrics and Director of the IBD Center at the Icahn School of Medicine at Mount Sinai. “It's reassuring to see that not only can we effectively recapture disease control with a convenient subcutaneous option, but that t
Galderma Announces Appointment of New Chief Financial Officer16.2.2026 08:00:00 EET | Press release
Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced the appointment of Luigi La Corte as Chief Financial Officer (CFO), effective May 1, 2026. Luigi La Corte will join Galderma on April 1 to begin a smooth and orderly transition with Thomas Dittrich, who has served as CFO of Galderma since October 2019. As previously announced, Thomas will remain with the company through Q2 2026 to ensure a seamless transition before pursuing another senior executive opportunity outside the organization. “Luigi La Corte is an accomplished financial leader with deep experience across global healthcare and consumer organizations. I am delighted to welcome him to the Executive Committee and look forward to working with him closely as we continue to execute our Integrated Dermatology Strategy and extend our category leadership in dermatology. I would also like to thank Thomas for his commitment to ensuring a seamless transition and his many contributions to Galderma dur
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