LACHEN, Switzerland-Saturday 2 November 2019 [ AETOS Wire ]
(BUSINESS WIRE)-- Octapharma has announced the publication of new data demonstrating that the fibrinogen concentrate fibryga® is an effective alternative to cryoprecipitate for patients with severe bleeding during cardiac surgery. The data were recently published in the Journal of the American Medical Association (JAMA).1
Excessive bleeding is a major concern during surgery, and excessive blood loss and/or clotting factor consumption can lead to deficiency in the coagulation factor fibrinogen. This acquired fibrinogen deficiency (AFD) can be treated with plasma-derived cryoprecipitate or with fibrinogen concentrates. Data on the use of fibrinogen concentrates in AFD have been limited until now. fibryga® is a highly purified, dual pathogen-inactivated, lyophilised human fibrinogen concentrate for intravenous infusion, with rapid reconstitution for effective correction of fibrinogen deficiency.
The latest data on the use of fibrinogen concentrates in AFD are from the FIBRES trial, a multicentre, single-blind, randomised, comparator-controlled trial conducted in Canada to assess noninferiority of fibryga® compared to cryoprecipitate in patients undergoing cardiac surgery. The trial enrolled 827 participants at 11 centres in Canada. In the publication, Dr Jeannie Callum and colleagues show that in these bleeding patients, the mean number of blood component transfusions needed for treatment, did not differ in patients receiving fibryga® or cryoprecipitate in the 24 hours after cardiopulmonary bypass (16.3 vs 17.0, respectively; p < 0.001 for noninferiority). There were no differences in adverse events in the two groups. The data met the study’s prespecified noninferiority criterion and led to early termination of the trial. Full results are available online here.
Previous studies evaluating efficacy and safety of fibrinogen concentrates for the treatment of patients with severe bleeding have been limited by study size. The FIBRES trial represents the largest randomised, comparator-controlled clinical trial of fibrinogen concentrates in severe bleeding; the final analysis includes more patients than in all previous studies combined.
The data are of particular importance for regions where cryoprecipitate is the current standard treatment for AFD, and support the use of fibryga® for management of bleeding in patients undergoing cardiac surgery.
fibryga® has a fixed, labelled content of fibrinogen and is double pathogen-inactivated. It supplied as a lyophilized powder that can be stored at room temperature and reconstituted within minutes. The reconstituted product is stable at room temperature for 24 hours. Conversely, Cryoprecipitate, must be thawed before use and must be used within 4 hours of thawing. The amount of Fibrinogen in Cryoprecipitate can vary considerably from preparation to preparation. In addition, the pooling of plasma during the preparation of cryoprecipitate carries potential risk of infectious transmission.
Olaf Walter, Board Member at Octapharma said that “patients undergoing major surgery are in a very vulnerable situation and the availability of convenient treatments is critical. These latest results add to the growing portfolio of positive data for fibryga® and we are proud to be able to contribute to the rapid and effective treatment for people experiencing excessive bleeding”
fibryga® is approved to treat congenital fibrinogen deficiency in 15 countries in the European Union, as well as in the US and Canada. In Switzerland, fibryga® is approved to treat both congenital fibrinogen deficiency and AFD.
fibryga® is a novel fibrinogen concentrate produced from pooled plasma providing fast reconstitution, dual pathogen safety, high level of purity, and functionality for the treatment of patients where fast and efficacious replacement of fibrinogen is needed. Indication of use may differ by country. Please consult local product information for country specific information or contact an Octapharma representative.
The vision of Octapharma is: “Our passion drives us to provide new health solutions advancing human life”. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. Our company values are Ownership, Integrity, Leadership, Sustainability and Entrepreneurship.
In 2018, the Group achieved €1.8 billion in revenue, an operating income of €346 million and invested €240 million into R&D and in capital expenditures in order to ensure future prosperity. Octapharma employs 8,314 people worldwide to support the treatment of patients in 115 countries with products across three therapeutic areas:
Haematology (coagulation disorders)
Immunotherapy (immune disorders)
Critical care (bleeding management and functional volume replacement)
Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden.
1 Callum et al. Effect of fibrinogen concentrate vs cryoprecipitate on blood component transfusion after cardiac surgery - The FIBRES randomized clinical trial. JAMA 2019. doi:10.1001/jama.2019.17312. Published online October 21, 2019.
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International Business Unit - Haematology
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