Coagulation factor VIIa (recombinant)-jncw(LFB Biotechnologies SASU)

LES ULIS, France--(BUSINESS WIRE)-- 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 and the acknowledgement of 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.

The advancement in technology that has endorsed manufacturing of recombinant proteins on a large scale industrial production for development of hemophilia and thrombosis treatments. Recombinant coagulation factors, as opposed to plasma-derived counterparts, consume a very low risk for transfer of infectious diseases and their use would eliminate the risk of infection from viruses such as the human immunodeficiency virus and hepatitis C. The advancement of recombinant coagulation factors has been a major importance in hemophilia care promising nearly complete safety of individuals from the risk of transmitted infections. Request Brochure for Report – Global Recombinant Coagulation Factors Market Witness Most Promising Rise in Demand: Rising number of hemophilia patients across the world, growing prophylactic treatment, and increasing demand for diagnosis rates for prevention of bleeding are likely to fuel the growth of recombinant coagulation factors market. In addition, increasing research and development activities on recombinant factor VIII is projected to boost the growth of the recombinant coagulation factors market. However, high cost treatment of hemophilia care and low cost treatment from plasma coagulation factor available alternatives to recombinant coagulation factors are obstructing the growth of recombinant coagulation factors market. While the R&D pipeline of recombinant coagulation factors is growing, other methods are strongly developing in early clinical development which may become the real threat to the recombinant coagulation factors market. The recombinant coagulation factors market can be segmented based on type, hemophilia type, end-user, and region. In terms of type, the market can be categorized into recombinant factor VIII, recombinant factor IXa, recombinant factor VIIa, and Von Willebrand factor. Recombinant factor VIIa or (rFVIIa) is available for treatment of people suffering from hemophilia with inhibitors who experience bleeding or require surgery. Recombinant or human plasma-derived factor IX products are used in the treatment and prevention of bleeding in patients with hemophilia B. Wide acceptance of recombinant coagulation factors throughout the developed world has considerably increased the supply of coagulation factor that concentrates and helped development of aggressive therapeutic interferences such as prophylaxis. Request for Analysis of COVID19 Impact on Recombinant Coagulation Factors Market – The global recombinant coagulation factors market can be segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the market, followed by Europe. Increasing demand for treatment and rising patient awareness about different treatment options drive the market in North America. The recombinant coagulation factors market is growing owing to increasing population and rising demand for rapid diagnosis and better treatment for hemophilia globally. In addition, the global recombinant coagulation factors market is expected to grow at a high rate in the next few years. Increasing medical tourism in developing countries, rising investments by market players in Asia Pacific, especially in India and China, and growing awareness about hemophilia treatment are likely to drive the market in Asia Pacific during the forecast period. Key Players of Recombinant Coagulation Factors Market Report: Key players operating in the global recombinant coagulation factors market are Bayer, Wyeth, Baxter International, Inc., P?zer, Inc., Novo Nordisk, Octapharma AG, Emergent BioSolutions Inc., CSL Behring, and Biogen. Increasing competition among key players to develop new therapy for hemophilia is projected to drive the recombinant coagulation factors market. Buy Recombinant Coagulation Factors Market Report – About Us Transparency Market Research is a global market intelligence company providing global business information reports and services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insight for several decision makers. Our experienced team of analysts, researchers, and consultants use proprietary data sources and various tools and techniques to gather and analyze information. Our data repository is continuously updated and revised by a team of research experts so that it always reflects latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports. Contact Transparency Market Research, 90 State Street, Suite 700, Albany, NY 12207 Tel: +1-518-618-1030 USA - Canada Toll Free: 866-552-3453 Website: