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
NIQ and INTAGE HD Partner to Expand Retail Measurement Across Japan and Global Markets24.4.2026 04:00:00 CEST | Press release
NielsenIQ (NYSE: NIQ), a leading consumer intelligence company, and INTAGE HOLDINGS Inc. (hereafter "INTAGE HD"), a leading market research company in Japan, today announced a mutual sales partnership to expand access to retail measurement insights between Japan and global markets. Through the collaboration, NIQ and INTAGE HD bring together complementary strengths— INTAGE HD’s deep local retail store panel data and insights into the Japanese domestic market, and NIQ’s global and regional retail store panel data and insights into various international markets—to enable better comparison and understanding of market performance and trends across countries and regions. This collaboration enhances both companies’ ability to support clients with more consistent and comparable insights, helping clients unlock growth opportunities across markets. The collaboration enables global clients to access INTAGE HD’s nationwide retail store panel data in Japan (SRI+ and SRI+EC) to support market entry
Andersen Global styrker sin vestafrikanske platform med tilføjelsen af et medlemsfirma i Ghana24.4.2026 03:46:00 CEST | Pressemeddelelse
Andersen Global fortsætter sin ekspansion i Afrika, hvor Lima Partners tilslutter sig som medlemsfirma og introducerer Andersen-navnet i Ghana. Det nuværende Andersen in Ghana blev stiftet i 2014, har hovedkontor i Accra og ledes af administrerende partner Daniel Addo Okoe. Firmaet tilbyder et komplet udvalg af professionelle services, herunder skatterådgivning, regulatorisk compliance, regnskab og rådgivning, transfer pricing, lønadministration, immigration og selskabsretlige sekretærydelser til både lokale og internationale klienter, der opererer i Ghana og den bredere vestafrikanske region. "At indtræde som medlemsfirma i Andersen Global markerer en betydelig milepæl for vores organisation," udtalte Kwame Amporful, seniorpartner hos Andersen in Ghana. "Vores kunder vil få glæde af forbedrede kompetencer på tværs af landegrænser, samtidig med at de beholder adgangen til praktisk kvalitetsrådgivning, der er skræddersyet til markedet i Ghana.” "Ghana spiller en afgørende rolle i at fre
Pacífico Mexinol Celebrates the Symbolic Groundbreaking in Topolobampo, Positioning Mexico in the New Low-Carbon Chemical Industry24.4.2026 02:29:00 CEST | Press release
The initiative brings together governments, diplomats, and global investors around a Net Zero industrial model. The project establishes Topolobampo, Sinaloa as a key hub for industrial development in North America. The Pacifico Mexinol project (“Mexinol”) celebrated the beginning of its pre-construction phase by symbolically laying a first stone, marking the start of one of the most significant global industrial investments in blue and ultra-low carbon methanol. The event brought together diplomats, authorities, and national and international business leaders, reflecting the project’s strategic importance for Mexico and its integration into the emerging low-carbon economy. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260423775301/en/ Adolfo Murietta, Project Shareholder; Rommel Gallo, CEO Transition Industries; Ron Johnson, United States Ambassador to Mexico; Drew Hoster, Counsel General of the United States in Hermosillo,
The New World ID: Proof of Human for the AI Era Scales Across the Digital Platforms People and Businesses Use Every Day24.4.2026 02:20:00 CEST | Press release
Docusign, Okta, Tinder, Vercel, and Zoom bring World ID proof of human to businesses, AI agents, and consumers Last week, World announced the next generation of World ID, its proof of human protocol, designed to increase trust on the internet. The announcement was made during “Lift Off,” a live event in San Francisco. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260417530721/en/ Docusign, Okta, Tinder, Vercel, and Zoom bring World ID proof of human to businesses, AI agents, and consumers As AI makes it easier than ever to generate convincing content, identities, and interactions, trust online has decreased. World ID addresses this challenge by enabling individuals to privately prove they are a real, unique human, without revealing their identity across apps, platforms, and services. “If anything online can be faked, you no longer know who or what to trust,” said Tiago Sada, Chief Product Officer at Tools for Humanity, a co
Cognite Positioned as a Front Runner in LNS Research Solution Selection Matrix for Industrial AI Platforms23.4.2026 20:00:00 CEST | Press release
Cognite, the global leader in Industrial AI, has been named a Front Runner in the LNS Research Solution Selection Matrix for Industrial AI Platforms (SSM). The LNS Research SSM evaluates vendors using a rigorous methodology that leverages its “3P” framework—Product, Potential, and Presence—to assess both current capabilities and future readiness. Within the report, Cognite is recognized in three key areas: depth in user-centric industrial AI applications, its knowledge graph-based data model, and its strong partner ecosystem. Together, all three give Cognite the ability to unify and contextualize complex industrial data, enabling organizations to operationalize AI at scale. “Cognite brings a sophisticated data model built for industrial complexities, along with advanced analytics and AI-driven insights, which is crucial for industrial organizations to achieve meaningful productivity gains and enterprise-wide ROI,” said Vivek Murugesan, Research Analyst at LNS Research. “These capabilit
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