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
Brenus Pharma Welcomes New European and Asia-Pacific Life Sciences Investors in Series A Extension20.7.2026 22:00:00 CEST | Press release
Brenus Pharma today announced an €11 million ($12.6M) extension to its Series A round, bringing total capital raised since inception to €38 million ($43.5M). This funding reflects strong execution across clinical, regulatory, and business development milestones, de-risking STC-1010 (NCT06934538): lead clinical-stage in-vivo immunotherapy for MSS mCRC, while positioning the company’s proprietary platform for multi-asset expansion. The round was supported by strong follow-on participation from existing investors, including Angelor, UI Investissement (managing FRAI), Crédit Agricole (CACE Création, CACF Capital Innovation), Noshaq, Orsa (formerly Investsud), BIO JAG, and Bpifrance (through non-dilutive funding). This round also welcomes two new international investors: Sambrinvest, strengthening the company’s European shareholder base, and Korea Omega Investment Corp, marking its first institutional investment from the Asia-Pacific region. "We couldn't be more confident in our first inves
Hollywood Chamber of Commerce Expands Into Luxury Hospitality20.7.2026 18:30:00 CEST | Press release
Hollywood Hotels & Residences to Bring the Spirit of Hollywood to Luxury Destinations Worldwide The Hollywood Chamber of Commerce, known for the iconic Hollywood Sign® and Hollywood Walk of Fame®, is expanding into luxury hospitality through a strategic partnership with The Scene Hotels & Resorts to launch Hollywood Hotels & Residences. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720026178/en/ The Scene Hotels & Resorts, with 40+ years of combined expertise in hospitality, travel, and brand development, will lead the brand’s development and management. The partnership will bring the Hollywood lifestyle to luxury hotels and branded residences around the world, creating immersive destinations inspired by the world's entertainment capital. "This partnership represents far more than an expansion of the Hollywood brand—it reflects our vision of Hollywood as the world's premier hub for entertainment, creativity, and commerce
Andersen Consulting udvider med samarbejdsfirmaet Smartbridge20.7.2026 17:54:00 CEST | Pressemeddelelse
Andersen Consulting annoncerer en samarbejdsaftale med Smartbridge, et Texas-baseret firma, der tilbyder digitale løsninger og AI-teknologi, og forbedrer dermed sine kapaciteter inden for data og analyse samt digitale transformationstjenester. Smartbridge blev grundlagt i 2003 og hjælper organisationer med at accelerere deres digitale transformation og modernisere driften gennem digital innovation, AI, data og analyse samt applikationsmoderniseringstjenester. Firmaet arbejder med kunder inden for olie- og gas-, medtech- og restaurationsbranchen og kombinerer rådgivnings- og teknologitjenester for at muliggøre erhvervsvirksomheders transformation og vækst. Ved at udnytte strategiske relationer med førende teknologileverandører hjælper Smartbridge organisationer med at forbinde data, forbedre beslutningstagning og accelerere forretningsresultater. "I dag ønsker organisationer at accelerere deres digitale omstilling og AI-transformation og søger praktiske måder at omsætte innovation til m
Epic Flight Academy Agrees to Purchase up to 50 Pipistrel Voyager Aircraft, Supplementing Its Fleet of Trainers as It Supports Continued Pilot Training20.7.2026 17:38:00 CEST | Press release
Pipistrel, a Textron Inc. (NYSE: TXT) company and an affiliate of Textron Aviation Inc., today announced Epic Flight Academy as the launch customer for the Pipistrel Voyager during Textron Aviation’s press conference at EAA AirVenture 2026. The company has signed a purchase agreement for up to 50 Voyager aircraft, with an order for 10 initial deliveries beginning in 2027, and options for up to 20 additional aircraft in 2028 and 20 in 2029, supporting the continued expansion of its training fleet and growing demand for pilot training. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720003143/en/ Epic Flight Academy agrees to purchase up to 50 Pipistrel Voyager aircraft, supplementing its fleet of trainers as it supports continued pilot training (Photo Credit: Pipistrel, a Textron Inc. company and an affiliate of Textron Aviation Inc.) Epic Flight Academy is a Florida-based flight training provider offering FAA Part 141 and
New Pipistrel Voyager Brings Next Generation Training Capabilities and Access to Flight Schools20.7.2026 15:00:00 CEST | Press release
Debuting at EAA AirVenture 2026 in Oshkosh, the world’s largest aviation gathering Pipistrel, a Textron Inc. (NYSE: TXT) company and an affiliate of Textron Aviation Inc., today introduced the Pipistrel Voyager, a next-generation training aircraft designed to expand capability for flight schools while maintaining the efficiency and simplicity owners and operators expect from Pipistrel. Purpose-built for evolving pilot training requirements, the Voyager is designed to align with anticipated Modernization of Special Airworthiness Certification (MOSAIC) regulations. This positions the aircraft to support broader training missions while improving access to pilot development. The aircraft is expected to enter into service in 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260720673571/en/ New Pipistrel Voyager brings next generation training capabilities and access to flight schools (Photo Credit: Pipistrel, a Textron Inc. c
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