LFB
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
First Cessna SkyCourier Delivered into Mexico, Expanding Air Freight Capabilities for FlexCoah22.12.2025 18:13:00 CET | Press release
The first Cessna SkyCourier in Mexico was recently delivered to cargo transportation provider FlexCoah for use by the company’s aviation subsidiary, Altair. The aircraft — a freighter variant — will expand the company’s air freight capabilities throughout the country. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251222890759/en/ First Cessna SkyCourier delivered into Mexico, expanding air freight capabilities for FlexCoah (Photo Credit: Textron Aviation) The Cessna SkyCourier is designed and manufactured by Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company. “The Cessna SkyCourier’s combination of reliability, payload capacity and mission flexibility makes it a powerful asset for operators looking to scale their operations while maintaining cost-efficiency,” said Lannie O’Bannion, senior vice president, Sales & Marketing. “The delivery of the Cessna SkyCourier to FlexCoah reflects the aircraft’s growing role in tran
Proudly Produced in Donegal: ProAmpac Invests in the Future of Food Board Manufacturing22.12.2025 17:34:00 CET | Press release
ProAmpac, a global leader in flexible packaging and material science, is strengthening its operational footprint with the expansion of Food Board manufacturing capabilities at its Donegal, Ireland campus. The addition of a new, purpose-built Food Board production area within the existing site reinforces ProAmpac’s commitment to innovation, efficiency, and customer service across the food packaging sector. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251222149380/en/ Carr & Sons Smoked Salmon - ProAmpac As an extension of the existing Donegal operations, which support the pet food, food-to-go, and CPG markets, the expanded production area increases capacity and precision. A state-of-the-art guillotine system delivers cleaner cuts and consistent board quality, ensuring every sheet meets ProAmpac’s performance standards. The expanded facility area introduces several key improvements for customers: Dedicated Customer Service T
Coherent Solutions closes strategic investment led by IceLake22.12.2025 16:07:00 CET | Press release
Coherent Solutions, a global digital engineering firm, has announced the closing of the strategic investment from IceLake, a leading private equity investor specializing in partnering with high-growth business services organizations. The transaction, previously announced in September 2025, has now received all necessary regulatory approvals. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251222791182/en/ Coherent Solutions and IceLake close strategic investment Coherent Solutions employs ~2,000 digital engineering, product, and design professionals across Europe and Latin America. The company builds and modernizes digital products and platforms for growing scale-ups and established global brands. “In a market saturated with AI claims, we’re seeing clients prioritize partners who can convert technology into measurable business outcomes,” said Igor Epshteyn, CEO of Coherent Solutions. “Staying grounded in digital value creatio
China Industry Leaders Convene in Jianshui to Chart the Blueberry Sector’s Growth Path22.12.2025 14:32:00 CET | Press release
The Third Yunnan Blueberry Conference and the release ceremony of the “Xinhua–Yunnan Honghe Blueberry Industry Development Index Report” opened on December 19 in Jianshui County, Honghe Hani and Yi Autonomous Prefecture, in southwest China’s Yunnan Province. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251222516223/en/ The opening ceremony of the conference on 19th Dec in Jianshui. The conference has attracted scholars, experts, business representatives, and purchasers from across China, who have gathered here to explore pathways for promoting the high-quality development of the blueberry industry. During the three-day conference, organizers convened two major signing ceremonies: a cooperation agreement to jointly establish the Yunnan Blueberry Research Institute, and a strategic agreement to enhance financial support for the full industrial chain of Honghe blueberries. Outstanding organizations and individuals contributin
Modon Holding Forms Joint Venture With Related Companies and Panepinto Properties to Deliver Harborside 4, a Luxury Residential Tower Along the Waterfront in the Heart of Downtown Jersey City22.12.2025 14:17:00 CET | Press release
Modon acquires a majority equity stake in Harborside 4, a prime 54-story development scheme in downtown Jersey City which will deliver 800 luxury rental apartments and condos in Q1 2029Joint venture with Related and Panepinto supports Modon’s ongoing strategy to diversify its global portfolio through high quality investments and strong international partnerships Modon Holding PSC (“Modon”) today announced a new joint venture to deliver Harborside 4, a 54-story residential tower on one of the last prime waterfront sites in downtown Jersey City, New Jersey, USA. Modon will hold a majority equity stake alongside leading US developer Related Companies and long-established Jersey City firm Panepinto Properties (the “Joint Venture”), marking a further milestone in the Group’s strategy to scale its diversified global portfolio. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251222455854/en/ Harborside 4 render (Photo: AETOSWire) Ha
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