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
Smartstream Introduces Agentic AI ‘Smart Agents’ for Investigations and Exceptions Handling4.12.2025 09:55:00 CET | Press release
Smartstream, the trusted data solutions provider for leading global financial institutions and enterprises, today announces the preview of Smart Agents for Investigations, a breakthrough in financial operations that brings augmented and autonomous exception handling to reconciliations and back-office processes. The new investigation agent combines domain-trained AI agents, workflow adoption, and embedded controls to triage, investigate, resolve, and learn from exceptions - reducing manual effort, accelerating time to resolution, and strengthening auditability. It will add a layer of intelligence on top of Smartstream’s current reconciliations and exceptions solutions. It understands the breaks context, adheres to customer playbooks and reaches out for missing information. It documents every step for audit and compliance, allowing analysts to focus on risk. Finally, it augments the analyst’s investigation with contextual information radically changing the user experience to review and a
LabGenius Therapeutics Announces New Collaboration with Sanofi for Multiple AI/ML-driven Antibody Optimisation Programmes4.12.2025 09:00:00 CET | Press release
The companies have entered into a new collaboration where LabGenius Therapeutics will apply its ML-driven antibody discovery platform (EVA™) to optimise potential therapeutic NANOBODY® proteins for multiple new targets LabGenius Therapeutics (“LabGenius”), a drug discovery company combining machine learning (ML) and high-throughput experimentation to optimise potential therapeutic antibodies, today announced a second collaboration with Sanofi. This collaboration combines LabGenius’ AI/ML-driven antibody design capabilities with Sanofi’s expertise in the development of therapeutic NANOBODY® molecules to co-optimise proteins for therapeutically valuable properties. Following the success of their first collaboration, LabGenius will apply the EVA™ platform to optimise NANOBODY® molecules for multiple new targets in the area of inflammation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251204759388/en/ “We are truly excited abo
GoWit One: The Unified AI Operating System Set to Revolutionize Commerce & Retail Media4.12.2025 07:09:00 CET | Press release
WPP Turkey has been selected as a pilot partner to deploy GoWit One, cutting campaign setup time to 10 minutes. GoWit, a global AdTech leader in omnichannel Commerce and Retail Media, announced the launch of GoWit One, the unified AI operating system that brings automation, unification, and real-time intelligence into a single ad platform for agencies operating across multiple retailers, channels, and markets. By bringing these three elements into one dashboard, GoWit One addresses the industry's most critical bottleneck: operational inefficiency. The platform enables agencies to manage campaigns across multiple retailers, channels, and markets, reducing manual AdOps workflows by 98%, turning a process that used to take hours into as little as 10 minutes. Solving the “Fragmentation Crisis” Despite the explosive growth of Retail Media, the industry faces a significant hurdle. According to the IAB, 70% of the market still lacks end-to-end AI adoption. Media buyers are currently forced to
Galderma Secures ‘BBB’ Credit Rating With Positive Outlook from S&P Global Ratings4.12.2025 07:00:00 CET | Press release
‘BBB’ long-term issuer credit rating from S&P Global RatingsPositive outlook, reflecting expected profitability improvement, ramp up of Nemluvio, and continued deleveraging and balance sheet improvementRecognition of Galderma’s science-based dermatology portfolio and global operations Galderma Group AG (SIX:GALD), the pure-play dermatology category leader, today announced that S&P Global Ratings (S&P) has assigned the company a ‘BBB’ long-term issuer credit rating with a positive outlook. The rating reflects Galderma’s strong track record of growth and its leading positions across Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. S&P notes the company’s well-established brand portfolio, global footprint, including an expanding presence in emerging markets, and continued investment in science-based innovation. S&P highlights momentum from recent launches, including Nemluvio® (nemolizumab), alongside improving profitability and expanding free operating cash flow
NTT DATA Announces Six New AI-Powered Cyber Defense Centers to Strengthen Cyber Resilience and Counter an Evolving Threat Landscape4.12.2025 04:30:00 CET | Press release
Four next-generation autonomous Cyber Defense Centers are now operational in India, with two additional centers planned in the UK in 2025 and the USA in 2026 Built with Agentic AI for SecOps, GenAI-driven threat orchestration and advanced automation that delivers up to 60% faster investigations and 90% fewer alerts Adds capacity for 800+ security analysts to protect global clients 24x7 through unified, AI-driven detection and response NTT DATA, a global leader in AI, digital business and technology services, today announced the launch of four next-generation autonomous Cyber Defense Centers powered by AI technologies in Bengaluru, Hyderabad, Noida and Mumbai, with two additional centers set to open in Birmingham (UK) in Dec 2025 and Dallas (USA) by Jan 2026. These purpose-built Cyber Defense Centers reinforce NTT DATA’s strategic focus on modernizing cybersecurity for the AI era. They represent a shift from traditional centralized security operations to a distributed, AI-driven, hyper-
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