Octapharma’s Fibryga® receives Health Canada approval to treat acquired fibrinogen deficiency (AFD) in surgical settings

Toronto, Canada
Press release

Octapharma Canada announces that Fibryga® (Human Fibrinogen Concentrate, HFC) has received Health Canada approval for use in treatment of acquired fibrinogen deficiency (AFD), in the course of surgical interventions. Fibryga® is a highly purified, dual pathogen-inactivated, lyophilized human fibrinogen concentrate for intravenous infusion, with a rapid reconstitution device and ability to infuse recommended dose in 10 minutes for effective correction of fibrinogen deficiency1.

The addition represents a major milestone for evidence-based bleeding management and informed decision making for patients experiencing critical bleeding. Dr. Jeannie Callum, Professor of Laboratory Medicine and Pathobiology, University of Toronto and principal investigator of the FIBRES clinical trial commented: “The Health Canada approval of Fibryga® for acquired hypofibrinogenemia is a significant advance for patient safety and for the logistics of supplying blood to Canadians. Having access to a well evidenced, modern fibrinogen source for our bleeding patients that is virally inactivated will ensure we are prepared for the next blood borne infection that hits the blood system in Canada. In addition, the continued reliance on cryoprecipitate for fibrinogen replacement adversely affects the supply of platelets across the country – a product where not infrequently we are unable to have complete stocks in our blood banks across the country.”

The recently concluded FIBRES Canadian clinical study is the largest multicenter clinical trial investigating the efficacy and safety of Fibryga® in comparison to cryoprecipitate in patients undergoing heart surgery. The results from FIRBES have been published earlier in the Journal of the American Medical Association (JAMA)2. In the FIBRES trial, Dr. Callum and colleagues show that in these bleeding patients the tested HFC had the same expected efficacy as the conventional cryoprecipitate as shown by 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 non-inferiority). There were no differences in adverse events in the two groups.

Acquired hypofibrinogenemia is an important cause of surgical bleeding. In Canada, the mainstay of therapy for acquired hypofibrinogenemia in bleeding patients is cryoprecipitate. Health Canada’s approval of Fibryga® for this indication is an important advance because it provides clinicians with the option of rapidly replenishing fibrinogen with a purified, virally-inactivated product instead of cryoprecipitate,” commented Dr. Keyvan Karkouti, Chief of the Department of Anesthesia and Pain Management for the Sinai Health/ University Health Network (UHN)/Women’s College Hospital and co-investigator of the FIBRES trial.

Commenting on the approval, Sri Adapa, General Manager of Octapharma Canada said: ‘’The approval provides the opportunity for the Canadian blood system to make evidence based decisions in patient blood management protocols and reinforces our commitment to developing modern, evidence based treatment options for the patients with critical bleeds.’’

Dr. Oliver Hegener, Vice President- International Business Unit, Critical Care said: “The approval of Fibryga® in Canada for the treatment of acquired fibrinogen deficiency is based on the largest set of clinical data in this indication, made possible by an innovative, pragmatic clinical study design. Our partnership with leading Canadian clinical experts and regulatory agencies enabled us to collectively generate the evidence for better clinical guidance and an easier access to improved care in Canada and around the world.”

Dr. Sigurd Knaub, Senior Vice President, Clinical R&D said: ‘’Supporting the lead Investigators in finding a design that is feasible in clinics with a high probability of success was a challenge but a collaborative approach coupled with oversight of an excellent Data and Safety Monitoring Board finally resulted in the first successful phase 3 study with a Fibrinogen concentrate in an acquired fibrinogen deficiency indication.’’

To learn more about Fibryga® please visit: https://fibrygaresources.ca/ .

The FIBRES trial results are available here.

About Fibryga®

Fibryga® (Fibrinogen Concentrate [Human], 1 g/vial) is indicated for the treatment of acute bleeding episodes and perioperative prophylaxis in adult and pediatric patients with congenital afibrinogenemia and hypofibrinogenemia. Fibryga® may be used as a complementary therapy during the management of uncontrolled severe bleeding in patients with acquired fibrinogen deficiency in the course of surgical interventions. Fibryga® is produced from pooled plasma with dual pathogen safety safeguards and a high level of purity. Fibryga® can be reconstituted in 5 minutes and the recommended dose can be infused in 10 minutes with the added convenience of storage at room temperature. Please consult the product monograph for further prescribing information.

About Octapharma

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. Octapharma employs more than 10,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy, and Critical Care.

Octapharma has seven R&D sites and six state-of-the-art manufacturing facilities in Austria, France, Germany, Mexico and Sweden, with a combined capacity of approximately 8 million liters of plasma per annum. In addition, Octapharma operates more than 140 plasma donation centers across Europe and the US.

1. Fibryga® Product Monograph. Octapharma Canada Inc. July 16, 2020.

2. 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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Diseases & therapies

Critical care