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
Daiichi Sankyo Appoints Markus Kosch to Lead Europe Business as Part of New Commercialization Organization24.8.2026 10:00:00 CEST | Press release
Daiichi Sankyo (TSE: 4568) today announced the appointment of Markus Kosch, MD, as Head of Europe Business, effective April 1, 2027. In this role, he will lead the company's European business within the new globally integrated Commercialization Unit and serve as General Manager of Daiichi Sankyo Europe GmbH, with legal responsibility for the company in Europe. The appointment reflects the next phase of growth of Daiichi Sankyo under its Five-Year Business Plan and the establishment of a new Commercialization Unit. Within this new structure, Markus Kosch will bring together the Oncology and Specialty businesses in Europe under one integrated leadership model to help bring innovative medicines to more patients across the region. For the past five years, Markus Kosch has led the Daiichi Sankyo Oncology Business Division in Europe and Canada, overseeing a period of significant growth and preparing the organization for an increasingly expanding oncology portfolio. Prior to joining Daiichi S
European Commission Approves DAYBU® (trofinetide) as the First and Only Treatment for Neurobehavioral Symptoms of Rett Syndrome in the European Union24.8.2026 09:01:00 CEST | Press release
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the European Commission (EC) has granted marketing authorization for DAYBU (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older, making it the first and only treatment approved for Rett syndrome in the European Union (EU). “The approval of DAYBU marks a significant milestone for the Rett syndrome community in the EU and advances our mission to bring this innovative treatment to patients and families who have long faced a profound unmet medical need,” said Catherine Owen Adams, Acadia’s Chief Executive Officer. “For people living with Rett syndrome, a devastating rare neurodevelopmental disorder, there have been no approved treatment options in the EU. We are proud to make DAYBU available and look forward to supporting patients, caregivers, and healthcare providers gain access to treatment." The DAYBU marketing authorization in the EU is prim
ORZEYFUL (oveporexton) Approved in Japan as the First and Only Medicine to Treat the Underlying Cause of Narcolepsy Type 124.8.2026 08:36:00 CEST | Press release
Discovered by Takeda in Japan, ORZEYFUL has the Potential to Redefine Care Beyond Individual Symptom Management for Adults Living with Narcolepsy Type 1 (NT1) Landmark Phase 3 Studies Demonstrated Significant and Meaningful Improvements Across the Full Range of NT1 Symptoms Evaluated in Clinical Trials Compared to Placebo Milestone Marks Third Major Regulatory Approval Secured for ORZEYFUL Around the World Takeda (TOKYO:4502/NYSE:TAK) announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved the use of ORZEYFUL (oveporexton) for the treatment of narcolepsy type 1 (NT1, narcolepsy with cataplexy) in adults. ORZEYFUL is a first-in-class oral orexin receptor 2 (OX2R) agonist and the only medicine indicated in Japan to treat the disease holistically rather than individual symptoms. The discovery of this new class of medicine originated in Takeda's laboratories in Japan. Takeda is proceeding with launch preparations and expects to make ORZEYFUL available as quickly
Fasset Hits $1B Valuation as SBI Group Leads $68M Series C to Scale AI-Powered Stablecoin Neobanking24.8.2026 08:03:00 CEST | Press release
Round led by SBI Group follows $51 million Series B raise in May 2026, marking ascent as one of the fastest-growing neobanking platforms. Capital will expand Own Network and deepen AI across stablecoin settlement, tokenization, and corridor banking. Fasset now processes more than $40 billion in annualized transaction volume, serving 3 million+ wallets and more than 1,000 enterprises across 125 countries. Fasset, the AI-powered stablecoin neobanking platform, today announced it has raised $68 million in Series C funding at a $1 billion valuation. The financing was led by SBI Group and follows Fasset’s $51 million Series B earlier this year, which brought Speedinvest onto the cap table alongside a group of strategic investors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260823503947/en/ Mohammad Raafi Hossain, Co-Founder and CEO, Fasset The new capital will support the expansion of Own Network, Fasset’s regulated financial
Zanders Expands DACH Region with New Office in Vienna, Austria24.8.2026 07:11:00 CEST | Press release
Zanders, the global treasury, risk, and technology consultancy, today announced a significant expansion of its DACH region with the opening of a new office in Vienna. The move builds on Zanders' continued growth across Germany, Austria, and Switzerland, and marks another step in the firm's strategy of deepening its presence in the markets where client demand for specialized treasury, risk, and corporate finance advisory is growing fastest. DACH has been one of Zanders' priority regions for several years, with the firm steadily expanding its team and client base across Germany and Switzerland. Austria represents a natural next step in that growth: in conversations with clients in the market, Zanders has seen growing interest in treasury transformation and financing support, as companies work through interest rate volatility, refinancing needs, and a broader shift toward more digitized, centralized treasury operations. The new Vienna office allows Zanders to be closer to clients' operati
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