FDA Approves 2-Gram Presentation of Fibryga for Acquired Fibrinogen Deficiency

Announced by parent company Octapharma USA, Inc., on January 7, 2026, the US Food and Drug Administration (FDA) has approved a 2-gram presentation of Fibrinogen (Human) Lyophilized Powder for Reconstitution (Fibryga) for fibrinogen replacement in patients with acquired fibrinogen deficiency (AFD).1

Initially approved as a 1-gram single-dose bottle in 2024, Fibryga is the first and only virus-inactivated, human plasma-derived fibrinogen concentrate approved for AFD in the US. Its lyophilized powder formulation allows it to rapidly reconstitute at the point of care, offering a more direct and consistent alternative to cryoprecipitate. This updated kit also contains 100 mL of Water for Infusion (WFI) and continues to feature the nextaro reconstitution device.1

“The introduction of the 2-gram Fibryga kit is a direct response to the needs of clinicians managing critical bleeding,” Flemming Nielsen, president of Octapharma USA, said in a statement. “By simplifying preparation and expanding dosing flexibility, we’re helping providers act faster and more precisely – when every second counts.”1

Fibryga’s initial FDA approval was based on positive results from the landmark FIBRES study, a multicenter randomized clinical trial investigating patients undergoing cardiac surgery and requiring fibrinogen replacement due to significant bleeding related to acquired hypofibrinogenemia. Investigators in FIBRES aimed to determine the noninferiority of fibrinogen concentrate to the standard-of-care treatment cryoprecipitate, as measured by the amount of allogeneic blood components administered, including red cells, platelets, and plasma.2

Patients were eligible for inclusion if they were undergoing cardiac surgery requiring cardiopulmonary bypass (CPB) and had fibrinogen supplementation ordered by clinicians in response to post-CPB hemorrhage in the presence of confirmed or suspected acquired hypofibrinogenemia. Patients were excluded if they had received fibrinogen concentrate or cryoprecipitate within 24 hours prior to surgery or had a history of severe allergic reaction to either drug, among other criteria.3

A total of 15,412 patients underwent cardiac surgery at the 11 participating sites – of these, 725 were screened and randomly assigned in a 1:1 ratio to either 4g fibrinogen concentrate, infused over roughly 10 minutes (n = 372), or 10 units cryoprecipitate, infused according to local practice (n = 363). Patients only received the allocated product for 24 hours after CPB, after which only cryoprecipitate was used.2

Ultimately, mean allogeneic blood component units administered were 16.7 units (standard deviation [SD], 16.4) within 24 hours after termination of CPB and 22.4 units (SD, 23.1) from beginning of surgery to postoperative day 7. Mean 24-hour post-bypass cumulative allogeneic blood component transfusions were 16.3 (95% CI, 14.9 to 17.8) units in the fibrinogen concentrate arm and 17 (95% CI, 15.6 to 18.6) units in the cryoprecipitate group. The mean ratio was 0.96 (1-sided 97.5% CI, -∞ to 1.09; P <.001 for noninferiority; 2-sided 95% CI, 0.84 to 1.09; P = .5 for superiority).2

Investigators also recorded noninferiority for the secondary outcomes of individual 24-hour and cumulative 7-day blood component transfusions, as well as in a post hoc outcome of cumulative transfusions measured from product administration to 24 hours after termination of CBP (mean units, 8.6 [95% CI, 7.5 to 9.9] in fibrinogen concentrate versus 8.9 [95% CI, 7.8 to 10.2] in the cryoprecipitate group; mean ratio, 0.97 [1-sided 97.5% CI, -∞ to 1.13; P = .02 for noninferiority]).2

Fibryga is now approved for fibrinogen supplementation in both congenital and acquired fibrinogen deficiency and is available in 1-gram and 2-gram kits, both of which use the nextaro device.1

“Octapharma continues to invest in innovations that improve outcomes for patients with serious bleeding complications,” Huub Kreuwel, PhD, vice president of medical affairs at Octapharma USA, said in a statement. “The new 2-gram Fibryga kit is another step forward in our mission to redefine the standard of care in hemeostasis.”1

References

1. Octapharma USA, Inc. FDA Approves New 2-Gram Presentation of Fibryga, Enhancing Convenience and Precision in Treating Acquired Fibrinogen Deficiency. PR Newswire. January 7, 2026. Accessed January 7, 2026. https://prnmedia.prnewswire.com/news-releases/fda-approves-new-2-gram-presentation-of-fibryga-enhancing-convenience-and-precision-in-treating-acquired-fibrinogen-deficiency-302654022.html

2. Callum J, Farkouh ME, Scales DC, et al. Effect of fibrinogen concentrate vs cryoprecipitate on blood component transfusion after cardiac surgery. JAMA. 2019;322(20):1966. doi:10.1001/jama.2019.17312

3. Karkouti K, Callum J, Rao V, et al. Protocol for a phase III, non-inferiority, randomised comparison of a new fibrinogen concentrate versus cryoprecipitate for treating acquired hypofibrinogenaemia in bleeding cardiac surgical patients: The fibres trial. BMJ Open. 2018;8(4). doi:10.1136/bmjopen-2017-020741