LACHEN, Switzerland--(BUSINESS WIRE)--Octapharma announced today that the human fibrinogen concentrate fibryga® has received approval for use in treatment of acquired fibrinogen deficiency (AFD) in 15 European countries. The approval extends the market authorisation for fibryga®, which is already approved for use in patients with congenital fibrinogen deficiency. The addition represents a major milestone for bleeding management in critical care settings.
Fibrinogen is a coagulation factor essential for blood clotting, and therefore to stop excessive bleeding. Unlike with rare congenital fibrinogen deficiencies, AFD arises when excessive blood loss, and so clotting, caused by trauma or major surgery use up the fibrinogen reserves in the blood. Fibrinogen replacement is a recommended first line therapy in the management of patients developing complications from uncontrolled bleeding.
Fibryga® is a highly purified, dual pathogen-inactivated, lyophilised human fibrinogen concentrate for intravenous infusion, with a rapid, convenient reconstitution device for effective correction of fibrinogen deficiency.
The approval of fibryga® for use in AFD is based on results of the FORMA-05 clinical study. This phase II, prospective, randomised, single-blind, controlled, non-inferiority study compared the efficacy of fibryga® with that of standard of care (cryoprecipitate) during cytoreductive surgery to treat the rare cancer Pseudomyxoma peritonei. This major and complex surgical procedure is associated with extensive blood loss and patients are at high risk of developing AFD.
The haemostatic efficacy was achieved by 100% for fibryga® and for cryoprecipitate. Levels of the fibrin-stabilising factor XIII were maintained in both treatment groups. However, patients treated with fibryga® experienced more rapid and pronounced replenishment of plasma fibrinogen levels and blood clot firmness. No thromboembolic events were reported in patients treated with fibryga® (n = 22) compared with seven in those treated with cryoprecipitate (n = 23).
Importantly, fibryga® was administered an average of 24 minutes earlier than cryoprecipitate, reflecting its rapid reconstitution and ease of use. This is especially important for situations where time to treatment is critical for patient outcomes.
Olaf Walter, Board Member at Octapharma, commented that “Fibrinogen replacement is an important strategy for management of bleeding, particularly in the surgical setting. The label extension represents an important step in the product’s development. We at Octapharma are proud to be contributing to rapid and effective bleeding control in this critical clinical setting as part of our goal of improving the lives of patients”.
Sigurd Knaub, Senior Vice President of Clinical R&D at Octapharma, added: “The FORMA-05 trial represents the first analysis of fibryga® in a controlled clinical study of AFD, and provides conclusive evidence for regulatory approval of a label extension.”
If you want to learn more about AFD and fibryga® please visit: https://www.fibrinogendeficiency.com
The FORMA-05 trial results are available here.
Roy A et al. J Thromb Haemost 2019. Publication accepted and in process.
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.