FDA approves fibryga for acquired fibrinogen deficiency, potentially ushering in a new standard of care – OctaPharma

Octapharma USA, Inc. has announced the expanded approval of fibryga, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for fibrinogen replacement in bleeding patients with acquired fibrinogen deficiency (AFD) by the FDA).

As the first and only on-demand, virus-inactivated, human plasma-derived fibrinogen concentrate option with this approval, fibryga represents a rapid and more precise option for severe bleeding scenarios than the current standard of care (cryoprecipitate).

Fibrinogen plays an important role in coagulation and blood clotting in emergency and surgical settings. Fibrinogen is the first coagulation factor to drop to critically low levels during severe bleeding episodes. Rapid replenishment of fibrinogen is essential for achieving hemostasis in bleeding patients. Acquired fibrinogen deficiency (AFD) often results from severe bleeding and can impair blood clot formation, increasing the risk of ongoing hemorrhage in patients. Cryoprecipitate, which was introduced in 1964, comes with significant drawbacks, including long thawing and preparation processes, variable levels of fibrinogen, inclusion of additional coagulation-dependent components, and a higher risk of viral transmission.

The approval of fibryga for AFD is a major advancement from the current standard of care. As a lyophilized powder, it can be stored at room temperature or refrigerated and can be quickly reconstituted at the point of patient care. It’s precise and delivers a highly purified and consistent amount of fibrinogen for accurate treatment.

The expanded FDA approval of fibryga was based on the FIBRES [FIBrinogen REplenishment in Surgery] study published in JAMA, which was a head-to-head, multicenter, randomized clinical trial in 735 patients, demonstrating that fibrinogen concentrate was non-inferior to cryoprecipitate and may be used instead of cryoprecipitate for the treatment of bleeding related to AFD. Fibryga® has already received regulatory approval for the treatment of AFD in both the European Union in 2019 and Canada in 2020.

Today’s approval marks the third FDA approval received to date for fibryga. In 2017, the FDA granted an approval for acute bleeding episodes in adults and adolescents with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. A second was received in 2020 for pediatric patients under 12 years for treatment of acute bleeding episodes in congenital fibrinogen deficiency.

See– October 21, 2019- “Effect of Fibrinogen Concentrate vs Cryoprecipitate on Blood Component Transfusion After Cardiac Surgery: The FIBRES Randomized Clinical Trial”;Jeannie Callum, MD; Michael E. Farkouh, MD; Damon C. Scales, MD; Nancy M. Heddle, MSc; Mark Crowther, MD; Vivek Rao, MD; et al., for the FIBRES Research Group.JAMA. 2019; 322(20):1966-1976. 10.1001/jama.2019.17312.

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