Business Wire

LFB Announces the Approval of CEVENFACTA® (eptacog beta) in the European Union

Share

LFB today announced that the European Medicines Agency (EMA) has granted on July 15th a Marketing Authorisation for CEVENFACTA® (eptacog beta), as the first new bypassing agent in over 20 years. CEVENFACTA® is indicated in adults and adolescents (12 years of age and older) for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:

  • in patients with congenital haemophilia with high-responding inhibitors to coagulation factors VIII or IX (i.e. ≥5 Bethesda Units (BU));
  • in patients with congenital haemophilia with low titre inhibitors (BU <5), but expected to have a high anamnestic response to factor VIII or factor IX administration or expected to be refractory to increased dosing of FVIII or FIX.

Denis Delval, LFB’s Chairman and Chief Executive Officer, stated: “We are very pleased with the approval of CEVENFACTA® by the EMA, which provides a new treatment option for haemophilia patients with inhibitors in the European Union. This approval is a validation of our innovative LFB technology andthe acknowledgementof LFB’s deep commitment to patients.”

Dr. Patrick Delavault, MD, LFB’s Executive Vice President Scientific, Medical and Regulatory Affairs, stated: “We need to keep in mind constantly what a bleeding event, even a single bleeding event, means to a haemophilia patient with inhibitors and to his family. This novel treatment alternative is a significative opportunity to improve patients’ lives”.

LFB has been granted a Marketing Authorisation for SEVENFACT® (eptacog beta) in Mexico on June 2nd for the treatment of bleeding episodes in adults and adolescents with haemophilia A or B with inhibitors.

About PERSEPT studies:

The approval of CEVENFACTA® was based on data from the phase III clinical trials, PERSEPT 1 and PERSEPT 3.

The PERSEPT 1 Phase III, multicentre, randomised, open-label crossover study of two initial dose regimens (75µg/kg and 225µg/kg), evaluated 468 bleeding episodes across the full type of severity of bleeding episodes (mild, moderate, and severe), in 27 adolescent and adult haemophilia A and B patients with inhibitors (12-54 years of age). Both dosing regimens met the primary endpoint with 81% and 90% of bleeds controlled at 12 hours with the 75µg/kg dose and the 225µg/kg dose respectively. By 24 hours, haemostatic efficacy (secondary endpoint) was retained in 96.7% of bleeding episodes treated with the 75 µg/kg dose regimen and 99.5% of redundancy bleeding episodes treated with the 225 µg/kg dose, without requiring any alternative therapy. The median time to attain haemostatic efficacy was 5.98 hours for the 75 µg/kg dosing regimen and 3 hours for the 225 µg/kg dosing regimen. A median of 2 injections was needed to treat a bleeding episode with the 75 µg/kg and a median of only 1 injection of the 225 µg/kg dosing regimen was needed.

The PERSEPT 3 Phase III, multicentre, open-label, single-arm study evaluated the safety and efficacy of CEVENFACTA® in haemophilia A or B patients with inhibitors who were scheduled for an elective surgical or other invasive procedure. 12 patients were enrolled in the study, 6 with minor procedures and 6 with major procedures. For major surgical/invasive procedures, treatment was administered at an initial bolus dose of 200 µg/kg immediately before the start of the invasive procedure. For a minor elective surgical procedure, an initial bolus dose of 75 µg/kg was administered immediately before the start of the procedure. Overall, 81.8% of procedures were reported as successfully treated at 48 hours after the last administration of the product.

No thromboembolic events were reported in these two clinical trials. No Serious Adverse Events (SAEs) were considered as related to the treatment.

Patients should be monitored for any signs of thrombosis, hypersensitivity and neutralising antibodies. The most frequently reported adverse reactions in studies were infusion site discomfort, infusion site haematoma, post-procedural haematoma, infusion related reaction, increased body temperature, dizziness and headache.

About LFB

LFB is a bio-pharmaceutical group that develops, manufactures and markets plasma derived products and recombinant proteins for the treatment of patients with serious and often rare diseases. LFB was founded in 1994 in France and is among the leading European bio-pharmaceutical companies providing mainly hospital-based healthcare professionals with blood-derived therapeutics with the vision to provide treatment options to patients in three major areas: immunology, haemostasis, and intensive care.

LFB currently markets 15 biomedicinal products in more than 30 countries.

Please visit www.groupe-lfb.com for further information on LFB.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

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

About Business Wire

Business Wire
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

Nonprofit Funding Platform Heroe5 Launches The Good Society, Embracing Web3 Approach to the Sustainable Financial Benefit for Charities9.8.2022 19:00:00 CEST | Press release

Nonprofit funding platform Heroe5™ announced today the creation ofThe Good Society™to address the growing need for sustainable funding platforms for charitable organizations. The Good Society becomes the first project focused on Web3 solutions to raise awareness and support global causes working to positively impact our communities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220728005376/en/ “The Good Society is a vital next step in the evolution of the fundraising industry: a Web3 platform to create art impact experiences,” said Sebastien Heimann, founding member and CEO of Heroe5 and The Good Society. “As the world moves to Web3, charities need more fundraising tools to stay ahead of the curve and embrace new ways to engage potential donors. The Good Society will provide those innovations, allowing them to raise critical funding and awareness for vital causes while feeding the public’s growing interest in digital colle

The Nature Conservancy and Global Partners Hold Session on Improving Protected Marine Areas at UN Oceans Conference With Support From Mary Kay Inc.9.8.2022 18:33:00 CEST | Press release

The United Nations Ocean Conference 2022 took place from June 27 to July 1, in Lisbon, Portugal, and brought together more than 5,000 participants, including world leaders, entrepreneurs, youth, influencers, and scientists. The conference aimed to facilitate these stakeholders in finding science-driven innovations and solutions to respond to a multidimensional ocean crisis driven by climate change, overfishing, habitat loss, and pollution. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220809005180/en/ The Nature Conservancy logo (Logo: The Nature Conservancy) The Nature Conservancy (TNC), with support from Mary Kay Inc., held an event in collaboration with United Nations Environment Programme (UNEP), the Government of Ecuador, the Jocotoco Foundation, the Charles Darwin Foundation for the Galapagos Islands, Re:wild, and the Marine Conservation Institute. TNC and UNEP moderated the event, highlighting the critical importance

Forescout Joins CISA’s Joint Cyber Defense Collaborative9.8.2022 18:00:00 CEST | Press release

Forescout Technologies Inc., the global leader in automated cybersecurity, today announced it has joined the Joint Cyber Defense Collaborative (JCDC) to further support the U.S. government’s focus on the cybersecurity and resilience of its industrial control systems and operational technology (ICS/OT). Established by the Cybersecurity and Infrastructure Security Agency (CISA), JCDC connects cyber defenders to enable critical thinking and planning against cyberattacks. “It’s an honor to be included in the newly expanded JCDC-ICS to share Forescout’s leadership and deep expertise in ICS/OT security,” said Tim Jones, Forescout’s US Federal Government VP of Systems Engineering. “Having worked directly with CISA for years, I know this type of collaboration between industry leaders in cybersecurity is exactly what our nation needs to protect against cyberattacks that threaten critical infrastructure systems on which our daily lives depend.” Forescout’s cybersecurity solutions are used by man

Simplifying Software Security: Veracode Enhances Frictionless Experience for Developers9.8.2022 16:50:00 CEST | Press release

Black Hat (booth #2428) – Veracode, a leading global provider of application security testing solutions, today announced the enhancement of its Continuous Software Security Platform with substantial improvements to its integrated developer experience. New features include extended integrations to support software composition analysis (SCA), a software bill of materials (SBOM) Application Programming Interface (API), and additional language and framework support for static analysis, further enhancing developers’ ability to secure software in the environments where they work. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220809005141/en/ Fig. 1 Veracode “Beat the Heat” security flaw heat map, State of Software Security Report v12 (Graphic: Business Wire) Brian Roche, Chief Product Officer at Veracode, said, “Modern applications are mostly assembled, not written from scratch. Open-source code makes up a significant proportion

TNS Targets Global Growth with Strategic Acquisition of AGNITY Global9.8.2022 16:01:00 CEST | Press release

Transaction Network Services (TNS) has today announced the acquisition of AGNITY Global, a leading provider of intelligent business communication applications and infrastructure to organizations in the telecommunications and healthcare industry verticals. The move strategically enhances TNS’ Communications Market global capabilities through AGNITY’s established channel partnerships business model that spans more than 12 countries. It will also enable TNS’ existing customers to benefit from a broader portfolio of next generation solutions. Headquartered in Silicon Valley with development and support operations in Richardson, Texas and Noida, India, AGNITY powers the networks of many global Tier-1 service providers via its scalable, carrier-grade Communication Application Server (CAS). This network agnostic, multi-service software platform offers app components and open APIs that enable service providers to address network technology transition challenges as well as future-proofing their

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