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
Venture Global and Vitol Announce New LNG Purchase Agreement23.3.2026 11:00:00 CET | Press release
Today, Venture Global, Inc. (NYSE: VG) and Vitol announced the execution of a new, binding agreement for the purchase of approximately 1.5 million tonnes per annum (MTPA) of U.S. liquefied natural gas (LNG) from Venture Global for five years commencing in 2026, to be supplied from Venture Global’s portfolio. “Global demand for flexible, reliable U.S. LNG is rapidly growing, and Venture Global is proud to work with premier LNG trading companies like Vitol to provide this critical supply to the market,” said Venture Global CEO Mike Sabel. “Thanks to our innovative model, we have the ability to provide our customers with short, medium, and long-term LNG supply, and this agreement is another important step in diversifying the tenor of our LNG portfolio.” “Vitol is delighted to be working with Venture Global, a leading producer and supplier of LNG to world markets,” said Pablo Galante Escobar, Global Head of LNG at Vitol. “LNG is important to many economies worldwide. Through this transacti
RSA Launches ID Plus Sovereign Deployment: The Next Level of High Assurance Identity Security23.3.2026 11:00:00 CET | Press release
New “Deploy Anywhere” Solution Sets Industry Standard for Security, Availability, and Compliance Across Critical Sectors Today at RSAC Conference 2026, RSA, the security-first identity leader, announced the launch of RSA® ID Plus Sovereign Deployment, a groundbreaking evolution in high assurance identity solutions designed to meet the needs of organizations that must maintain constant availability, meet policy and data sovereignty laws, and defend themselves from advanced, persistent threats. RSA ID Plus Sovereign Deployment is the next evolution in RSA® ID Plus, the market’s most secure identity and access management (IAM) security platform featuring complete multi-factor authentication (MFA), SSO, and access capabilities. RSA ID Plus Sovereign Deployment features a new “deploy anywhere” capability that allows government agencies, financial services, critical infrastructure, and healthcare organizations to modernize their identity infrastructure while still maintaining the highest sta
Klarna Expands Its Partnership With H&M in Romania and Hungary23.3.2026 10:46:00 CET | Press release
Today Klarna announces that H&M customers can now choose flexible Klarna payment options at checkout. The expansion comes amid Klarna's rapid growth in Romania, where the global digital bank and flexible payments provider has surpassed 500,000 active users. Klarna, a global digital bank and provider of flexible payment solutions, and H&M, one of the world's largest fashion retailers, announce the expansion of their partnership in Romania and Hungary as a strategic step that strengthens the long-standing global collaboration between the two companies. Klarna is now available as a payment method for H&M customers in both markets, offering a smooth, more predictable checkout experience and payment options tailored to the different needs of shoppers. The integration of Klarna into H&M online stores is an important feature for customers, who will thus be able to access interest-free flexible payment options. More flexibility at checkout By integrating Klarna into the payment process, H&M cu
Recyclable Packaging and Responsible Water Management: Barilla’s Commitment to a More Sustainable Future23.3.2026 10:30:00 CET | Press release
99.8% of the packaging sold is designed to be recyclable.Over 50% of the materials used in Barilla Group’s packaging are recycled, and 71% are paper-based.+45% water recycled and reused in 2024 compared to 2022, and +164% in water-stressed areas. With 99.8% of the packaging designed to be recyclable and a 45% increase in water recycled and reused in 2024 compared to 2022, Barilla continues to strengthen its commitment to the responsible management of resources. The company is reaffirming this commitment on the occasion of Global Recycling Day (March 18) and World Water Day (March 22), two moments that highlight the importance of increasingly sustainable production models – from efficient water management to the design of more circular packaging solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260320294356/en/ Barilla Group's Rubbiano Plant (PR) WATER AS A STRATEGIC RESOURCE TO PROTECT A fundamental resource for past
Massive Gaming Secures MGA B2B License to Expand Global iGaming Partnerships23.3.2026 10:13:00 CET | Press release
Massive Gaming (MVG), a global iGaming content provider with headquarters in Australia, has secured a B2B Gaming License from the Malta Gaming Authority (MGA), marking a key milestone in the company’s expansion into regulated international markets. The MGA license enables Massive Gaming to supply its gaming content and solutions to operators licensed under the Malta regulatory framework, strengthening the company’s ability to collaborate with partners across Europe and other regulated jurisdictions. To support its regulatory expansion, Massive Gaming established MVG Malta, a dedicated entity created as part of the licensing process, and which supports the company’s broader strategy to strengthen its presence within the European iGaming ecosystem. Massive Gaming develops its gaming portfolio across three studios - Slot Mart, Whale House and Blitzcrown. All three deliver a range of gaming experiences spanning traditional slot titles, regulated market content and emerging non-traditional
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