Business Wire

LFB Announces that the European Medicines Agency (EMA) Has Accepted for Filing the Marketing Authorization Application for eptacog beta (activated), a Recombinant Coagulation Factor VIIa

Share

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.

Contact information

LFB:
Didier Véron - Executive VP Corporate Affairs
Tel: +33 (0)1.69.82.72.97 or +33 (0)6.08.56.76.54
verondidier@lfb.fr

HEMA Biologics Contacts (US):
Chris Macie, Senior Director, Medical Affairs
Cell number: (+1) 770-331-5761 - chris.macie@hemabio.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Former Flex Executive Paul Humphries Joins Westfall Technik’s Board of Directors19.4.2021 04:19:00 EEST | Press release

Westfall Technik Inc. has added industry veteran Paul Humphries to its board of directors. Humphries worked with Westfall CEO Brian Jones and COO Mark Gomulka while at NASDAQ-listed Flex Ltd. (formerly Flextronics), and he has three decades of experience leading outsourced manufacturing services businesses. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210418005057/en/ Paul Humphries, a former long-time, senior Flex executive, brings a wealth of experience to Westfall's board. He has spent years in the medical industry building global, high-reliability businesses. (Photo: Business Wire) Until his retirement in November 2020, Humphries spent two decades at Flex, the 160,000-employee, Singapore-based, multinational electronics contract manufacturer. In his most recent role at Flex, Humphries served as president for its High Reliability Solutions (HRS) unit, which generated $11 billion in annual revenue and served the medical,

NielsenIQ and J.D. Power Enter Strategic Alliance to Bring Unparalleled Automotive Research to Major Growth Markets19.4.2021 04:00:00 EEST | Press release

NielsenIQ, an industry leader in global measurement, and J.D. Power, a global leader in data analytics and consumer intelligence, today announced their intent to launch a multinational strategic alliance to bring benchmark automotive customer experience studies and deep auto industry data analysis to major growth markets such as India, Southeast Asia and the Middle East. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210418005017/en/ Drawing on the strong market presence of NielsenIQ and the deep industry expertise of J.D. Power, the alliance will feature J.D. Power benchmark automotive studies, recognized as the gold standard in the automotive industry, complemented by NielsenIQ’s new digital and technology-based platforms and value-added services like social listening analysis. Combining NielsenIQ and J.D. Power capabilities will allow automotive sector clients to strategize for the future based on data-driven tools and in

Leading European Football Clubs Announce Participation in New Super League Competition19.4.2021 01:22:00 EEST | Press release

Twelve of Europe’s leading football clubs have today come together to announce they have agreed to establish a new mid-week competition, the Super League, governed by its Founding Clubs. AC Milan, Arsenal FC, Atlético de Madrid, Chelsea FC, FC Barcelona, FC Internazionale Milano, Juventus FC, Liverpool FC, Manchester City, Manchester United, Real Madrid CF and Tottenham Hotspur have all joined as Founding Clubs. It is anticipated that a further three clubs will join ahead of the inaugural season, which is intended to commence as soon as practicable. Going forward, the Founding Clubs look forward to holding discussions with UEFA and FIFA to work together in partnership to deliver the best outcomes for the new League and for football as a whole. The formation of the Super League comes at a time when the global pandemic has accelerated the instability in the existing European football economic model. Further, for a number of years, the Founding Clubs have had the objective of improving th

Advanced Eye Protection Against Covid-19 For Healthcare Professionals – an Exclusive Bollé Safety Technology16.4.2021 23:00:00 EEST | Press release

Bollé Safety, world leader in the design and manufacture of protective eyewear, presents its Healthcare division dedicated to all healthcare professionals. Its range of protective eyewear with anti-fog and anti-scratch PLATINUM® coating provides highly exposed employees with the highest levels of protection, clarity, and vision. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210416005009/en/ @BolléSafety - A.Childeric Viruses & infections’ protection Bollé Safety offers certified products compliant with the most stringent international standards. Its anti-fog PPE product range is tailored to protect professionals who are at high risk of being exposed to bodily fluids when providing care to patients. It is the company’s shared commitment to provide the highest quality protection for all healthcare workers. The importance of a clear vision Bollé Safety’s unique and exclusive permanent double sided anti-fog and anti-scratch PLA

Zeepay Ghana Acquires Mangwee Mobile Money in Zambia16.4.2021 20:55:00 EEST | Press release

Zeepay, the leading African Challenger Fintech with operations in over 10 African countries today acquired a 51 percent stake in Mangwee Mobile Money in Zambia. In a private placement Zeepay and Mangwee agreed to a sale of 51 percent of Mangwee shares to Zeepay. The deal makes Zeepay Ghana the majority shareholder of the entity. Mangwee has been in operations since 2018, and was initially set up to operate as an alternative wallet targeting university students in Zambia with the aim of assisting to drive the cost of mobile money services downward. Zeepay is the leading African challenger fintech with operations across 20 African countries and 30 day active in 10 of them. The company specializes in paying remittances into mobile money wallets across Africa and is regulated by both Bank of Ghana as an EMI issuer and in the UK as a Money Transfer Operator, by the Financial Conduct Authority. The merger is the first of its kind; that two Indigenous African fintechs into Mobile Money operat

CGTN: Leading With Action: China in the Fight for Carbon-Neutral Future16.4.2021 19:29:00 EEST | Press release

Climate change is not taking a break from wreaking havoc in 2020, with the joint highest global temperatures on record, rampant bushfires, the faster rates of sea level rise and the extinction of some species. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210416005435/en/ Under this circumstance, Chinese President Xi Jinping, French President Emmanuel Macron, and German Chancellor Angela Merkel held a virtual meeting Friday on climate change, ahead of the Leaders' Climate Summit on Earth Day convened by the U.S., scheduled next week. Emphasizing that he always advocates building a community with a shared future for mankind, the Chinese president voiced his willingness to strengthen cooperation with France and Germany on climate change. "Tackling climate change is a common cause for all mankind and it should not become a geopolitical bargaining chip, a target for attacking other countries, or an excuse for trade barriers," h

Colicity Inc. Announces the Separate Trading of its Class A Common Stock and Warrants, Commencing on or about April 16, 202116.4.2021 16:30:00 EEST | Press release

Colicity Inc. (the “Company”) announced that holders of the units sold in the Company’s initial public offering of 34,500,000 units, including the underwriters’ exercise of their full over-allotment option for 4,500,000 units, completed on February 26, 2021 (the “Offering”) may elect to separately trade the Class A common stock and warrants included in the units commencing on or about April 16, 2021. Any Units not separated will continue to trade on The Nasdaq Capital Market under the symbol “COLIU,” and the Class A common stock and warrants will separately trade on The Nasdaq Capital Market under the symbols “COLI” and “COLIW,” respectively. No fractional warrants will be issued upon separation of the units and only whole warrants will trade. Holders of units will need to have their brokers contact Continental Stock Transfer & Trust Company, the Company’s transfer agent, in order to separate the units into Class A common stock and warrants. This press release shall not constitute an o

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